Belantamab Mafodotin in Multiple Myeloma: A Comprehensive Review of a First-in-Class BCMA-Targeted Antibody-Drug Conjugate

Executive Summary and Drug Profile

Belantamab mafodotin represents a significant therapeutic innovation in the management of multiple myeloma (MM), standing as the first-in-class antibody-drug conjugate (ADC) designed to target B-cell maturation antigen (BCMA).[1] Its development and clinical journey have been characterized by both remarkable successes and notable setbacks, providing a compelling case study in modern oncology drug development. Initially granted accelerated and conditional approvals worldwide based on promising efficacy as a monotherapy in heavily pre-treated patients with relapsed or refractory multiple myeloma (RRMM), its standing was challenged when a pivotal confirmatory trial failed to meet its primary endpoint.[3] This led to a withdrawal of its marketing authorization in the United States and a non-renewal in the European Union.[3]

However, the therapeutic potential of belantamab mafodotin was ultimately realized through subsequent, well-designed Phase III trials evaluating its use in combination with established standards of care. These studies demonstrated profound and clinically meaningful improvements in both progression-free and overall survival, leading to a regulatory resurgence.[6] In 2025, belantamab mafodotin secured new marketing authorizations in the European Union and other key global markets for use in combination regimens, firmly re-establishing its role as a critical treatment option for patients with RRMM.[7] This report provides an exhaustive review of belantamab mafodotin, detailing its pharmacology, pharmacokinetic profile, the pivotal clinical trial data that have defined its trajectory, its unique safety considerations, and its complex global regulatory history.

Table 1: Belantamab Mafodotin Drug Profile Summary

Attribute	Value	Source(s)
Generic Name	belantamab mafodotin	9
Brand Name	Blenrep	3
DrugBank ID	DB15719	3
CAS Number	2050232-20-5	3
Type	Biotech, Antibody-Drug Conjugate (ADC)	1
ATC Code	L01FX15	3
Chemical Formula	C6484​H10008​N1728​O2030​S44​⋅(C49​H66​N6​O11​)4​	3
Target	B-cell maturation antigen (BCMA, CD269)	2
Drug Class	Miscellaneous antineoplastics	9
Developer/Sponsor	GlaxoSmithKline (GSK)	3

Pharmacology and Mechanism of Action

The therapeutic efficacy of belantamab mafodotin is rooted in its sophisticated molecular design as an ADC, which enables the targeted delivery of a potent cytotoxic agent directly to cancer cells while leveraging the patient's own immune system. This multi-modal mechanism of action distinguishes it from other therapeutic classes used in multiple myeloma.

The B-Cell Maturation Antigen (BCMA) Target

The selection of BCMA as a therapeutic target is central to the drug's specificity and success. BCMA, a member of the tumor necrosis factor (TNF) receptor superfamily, is a cell-surface protein whose expression is almost entirely restricted to mature B lymphocytes and plasma cells.[2] In the context of multiple myeloma, BCMA is universally upregulated on the surface of malignant plasma cells.[2] This selective expression makes it an ideal target, as it minimizes the potential for "off-tumor" toxicity in non-hematopoietic tissues.[2]

During the malignant transformation of plasma cells, the overexpression of BCMA and its corresponding ligands, A Proliferation-Inducing Ligand (APRIL) and B-cell Activating Factor (BAFF), leads to the constitutive activation of several critical oncogenic signaling pathways. These include the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB), protein kinase B (AKT), and signal transducer and activator of transcription 3 (STAT3) pathways.[2] This cascade of signaling promotes tumor cell growth, proliferation, survival, and the development of drug resistance. Preclinical evidence has demonstrated that inhibiting BCMA function, either by blocking ligand binding or targeting the receptor directly, can effectively decrease myeloma cell viability and colony formation.[2]

Molecular Structure of the Antibody-Drug Conjugate

Belantamab mafodotin is a complex biologic composed of three distinct components engineered to work in concert [2]:

1. The Monoclonal Antibody: The targeting component is belantamab, a humanized IgG1κ monoclonal antibody with high affinity and specificity for human BCMA.[2] A critical engineering feature of this antibody is that it is afucosylated, meaning it lacks fucose sugar residues on its Fc (fragment, crystallizable) region. This modification significantly enhances its binding affinity for Fc receptors on immune effector cells, such as natural killer (NK) cells, thereby potentiating its immune-mediated antitumor activity.[2]
2. The Cytotoxic Payload: The cell-killing agent is monomethyl auristatin F (MMAF), a potent synthetic antimitotic agent.[1] MMAF functions by disrupting microtubule polymerization, a process essential for the formation of the mitotic spindle during cell division.[2]
3. The Linker: The antibody and payload are connected by a stable, non-cleavable maleimidocaproyl (mc) linker.[2] The stability of this linker is crucial; it ensures that the highly toxic MMAF payload remains securely attached to the antibody while in systemic circulation, preventing premature release and minimizing systemic toxicity. The cytotoxic agent is only released following the internalization of the entire ADC into the target myeloma cell and subsequent proteolytic degradation of the antibody within the lysosome.[2] The drug-linker technology was licensed from Seagen Inc., and the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa, a member of the Kyowa Kirin Group.[18]

Multi-Modal Antitumor Activity

Belantamab mafodotin eradicates myeloma cells through a sophisticated, multi-pronged mechanism that combines direct cytotoxicity with immune system engagement and the disruption of key survival pathways.[1] This multifaceted approach is fundamental to its clinical activity, particularly in patients with disease refractory to other therapies.

1. Targeted Cytotoxicity and Apoptosis: Upon intravenous administration, the belantamab antibody binds to BCMA on the surface of myeloma cells. This binding triggers the internalization of the ADC-receptor complex into the cell.[1] Once inside the lysosomal compartment, the antibody component is degraded by proteases, releasing the MMAF payload into the cytoplasm.[2] The freed MMAF then exerts its cytotoxic effect by binding to tubulin and inhibiting microtubule polymerization. This disruption of the cellular cytoskeleton leads to cell cycle arrest at the G2/M checkpoint, preventing the cell from completing mitosis and ultimately inducing programmed cell death, or apoptosis.[2]
2. Immune System Engagement: In addition to delivering a cytotoxic payload, the antibody component of belantamab mafodotin actively recruits the patient's innate immune system to attack myeloma cells. The afucosylated Fc region of the antibody enhances its ability to mediate:

• Antibody-Dependent Cellular Cytotoxicity (ADCC): Immune effector cells, such as NK cells, recognize and bind to the Fc region of the belantamab antibody coating the myeloma cell, triggering the release of cytotoxic granules that lyse the tumor cell.[2]
• Antibody-Dependent Cellular Phagocytosis (ADCP): Phagocytic cells, like macrophages, are recruited to engulf and destroy the antibody-coated myeloma cells.[2] The contents released by the dying myeloma cells can further activate the immune system to find and destroy more tumor cells in a process known as immunogenic cell death.[1]

3. Disruption of Survival Signaling: The physical binding of belantamab mafodotin to the BCMA receptor on the cell surface also serves a direct anti-proliferative function. It competitively blocks the interaction between BCMA and its natural survival ligands, BAFF and APRIL.[16] This interference disrupts the downstream NF-kB signaling pathway, which is crucial for myeloma cell survival, thereby further promoting apoptosis.[2]

This combination of direct, targeted cell killing with two distinct forms of immune-mediated destruction and the blockade of a key survival pathway creates a powerful and synergistic antitumor effect. This inherent multi-modality within a single therapeutic agent helps to explain its profound efficacy, especially when used in combination regimens where it can complement the mechanisms of other drugs, such as proteasome inhibitors or immunomodulatory agents.

Pharmacokinetics and Dosing

The clinical application of belantamab mafodotin is guided by a well-characterized pharmacokinetic (PK) profile and an evolving understanding of the optimal dosing strategy required to balance its potent efficacy with its significant toxicity profile.

Pharmacokinetic Profile

Population pharmacokinetic (PopPK) modeling, based on data from the DREAMM-1 and DREAMM-2 studies, has provided a detailed understanding of the drug's behavior in patients.[11] The concentration-time profiles of the intact ADC, the total monoclonal antibody, and the released cytotoxic payload (cysteine-maleimidocaproyl-MMAF, or cys-mcMMAF) are best described by linear, two-compartment models featuring first-order elimination.[11]

A key and unusual characteristic of belantamab mafodotin's PK is its time-varying clearance. The initial typical clearance for the ADC is approximately 0.94 L/day, corresponding to an initial half-life of 11.5 days. However, over the course of treatment, this clearance rate decreases by about 28%, resulting in a prolonged terminal half-life of 14.3 days.[11] The time to reach 50% of this maximal change in clearance is approximately 50 days.[11] This phenomenon suggests the presence of target-mediated drug disposition, where the initial doses saturate the available BCMA targets on myeloma cells, leading to slower clearance of subsequent doses. The release of the cys-mcMMAF payload from the ADC is governed by deconjugation and proteolytic degradation, with the drug-to-antibody ratio (DAR) decreasing with a half-time of 10.3 days after each dose administration.[11]

Several patient-specific factors, or covariates, have been identified that significantly influence drug exposure. The most impactful covariates are those related to the patient's underlying disease state. Patients with a higher disease burden—as indicated by higher baseline levels of soluble BCMA (sBCMA) and immunoglobulin G (IgG), and lower levels of serum albumin—exhibit higher drug clearance and consequently lower systemic exposure to the ADC.[11] Body weight also influences clearance and the volume of distribution. Notably, other clinical factors such as age, ethnicity, mild-to-moderate renal impairment, and mild hepatic impairment were found to have no clinically significant impact on the drug's pharmacokinetics, simplifying dosing considerations in these common patient populations.[11]

Dosage and Administration

The dosing regimen for belantamab mafodotin has evolved significantly from its initial approval as a monotherapy to its current use in combination therapies, reflecting a data-driven effort to optimize its therapeutic index.

• Initial Monotherapy Regimen: The original accelerated approvals were based on a recommended dosage of 2.5 mg/kg of actual body weight, administered as an intravenous infusion over approximately 30 minutes once every 3 weeks (Q3W).[21]
• Current Combination Regimens (EU Approval): The successful DREAMM-7 and DREAMM-8 trials established new dosing standards for combination use [6]:
• In combination with bortezomib and dexamethasone (BVd): The recommended dose is 2.5 mg/kg IV Q3W.[20]
• In combination with pomalidomide and dexamethasone (BPd): The recommended schedule is 2.5 mg/kg IV for the first cycle, followed by a reduced dose of 1.9 mg/kg IV administered once every 4 weeks (Q4W).[23]

This shift in dosing, particularly in the BPd regimen, represents a critical adaptation. The initial, more intensive schedules were associated with high rates of ocular toxicity, leading to frequent dose interruptions and modifications, a concern highlighted by regulatory bodies.[25] The success of the DREAMM-8 trial with a lower-dose (1.9 mg/kg), longer-interval (Q4W) schedule demonstrated that maximal efficacy could be maintained with a less intensive regimen. This finding suggests that the drug's long half-life and sustained mechanism of action allow for less frequent administration, which is crucial for managing the cumulative, on-target/off-tumor toxicity observed in the cornea and enhancing the overall tolerability and clinical utility of the drug.

• Dose Modifications: Dose reduction to 1.9 mg/kg is the primary strategy for managing adverse reactions, particularly ocular toxicity and thrombocytopenia. Treatment with belantamab mafodotin should be permanently discontinued in patients who are unable to tolerate a dose of 1.9 mg/kg.[21]
• Preparation and Administration: Belantamab mafodotin is supplied as a 100 mg lyophilized powder in a single-dose vial. It must be reconstituted by a healthcare professional with 2 mL of Sterile Water for Injection, USP, to yield a 50 mg/mL solution. The calculated dose is then withdrawn and diluted in a 250-mL infusion bag of 0.9% Sodium Chloride Injection, USP, using polyvinylchloride (PVC) or polyolefin (PO) bags. Throughout preparation, the solution should be mixed by gentle swirling or inversion and must not be shaken to prevent protein aggregation.[21]

Clinical Efficacy: The DREAMM Clinical Trial Program

The clinical development of belantamab mafodotin has been defined by the ambitious DRiving Excellence in Approaches to Multiple Myeloma (DREAMM) clinical trial program. The results from these trials tell a compelling story of initial promise, a significant regulatory setback, and an ultimate redemption that has reshaped the treatment landscape for RRMM.

DREAMM-2: Initial Promise in Heavily Pretreated Patients

The foundation for belantamab mafodotin's initial approvals was laid by the DREAMM-2 study (NCT03525678), a pivotal Phase II, open-label, multicenter trial.[1] This study enrolled patients with heavily pretreated RRMM who had received at least three prior lines of therapy and whose disease was refractory to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody.[26] This "triple-class refractory" population represents a group with a very poor prognosis and limited treatment options.

Patients were randomized to receive belantamab mafodotin monotherapy at either 2.5 mg/kg or 3.4 mg/kg intravenously every 3 weeks.[1] The efficacy results for the now-recommended 2.5 mg/kg dose were clinically meaningful and durable. The study demonstrated an

overall response rate (ORR) of 31% (97.5% confidence interval [CI]: 21-43%).[3] Importantly, these responses were lasting; 73% of responding patients had a

duration of response (DoR) of at least 6 months, with a median DoR of 11 months.[3] These data, demonstrating significant activity in a patient population with high unmet need, formed the basis for the initial accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2020 and a conditional marketing authorization from the European Medicines Agency (EMA) in the same month.[21]

DREAMM-3: The Confirmatory Trial Setback

As a condition of its accelerated approval, a confirmatory Phase III trial was required to verify the clinical benefit of belantamab mafodotin. The DREAMM-3 study (NCT04162210) was designed for this purpose.[4] It was an open-label, randomized (2:1) trial that compared belantamab mafodotin monotherapy (2.5 mg/kg Q3W) against an active standard-of-care comparator, pomalidomide plus low-dose dexamethasone (PomDex), in patients with RRMM who had received at least two prior lines of therapy.[29]

The trial failed to meet its primary endpoint of demonstrating a statistically significant improvement in progression-free survival (PFS) for belantamab mafodotin compared to PomDex. At a median follow-up of approximately 11 months, the median PFS was 11.2 months in the belantamab mafodotin arm versus 7.0 months in the PomDex arm; however, this difference was not statistically significant (Hazard Ratio 1.03; 95% CI: 0.72-1.47; p=0.56).[29]

Although the trial failed its primary endpoint, secondary analyses did reveal signals of activity. Belantamab mafodotin induced deeper responses, with a very good partial response (VGPR) rate or better of 25% compared to just 8% for PomDex, and the median DoR was substantially longer (not reached vs. 8.5 months).[31] Nevertheless, the failure to demonstrate superiority in PFS, as required by the regulatory mandate, had severe consequences. At the request of the FDA, GSK initiated the withdrawal of the U.S. marketing authorization in November 2022.[3] Subsequently, the EMA's conditional authorization was not renewed in February 2024.[5] This setback was not necessarily an indictment of the drug's activity but rather a reflection of a trial design that may have been ill-suited to demonstrate superiority for a potent monotherapy against an active doublet comparator, particularly given the statistical complexities of non-proportional hazards observed in the data.[33]

Redemption Through Combination Therapy: DREAMM-7 and DREAMM-8

The true potential of belantamab mafodotin was unlocked in two subsequent pivotal Phase III trials that evaluated its use in combination regimens, fundamentally redefining its clinical role.

DREAMM-7: Superiority with a Bortezomib Combination (BVd)

The DREAMM-7 trial (NCT04246047) was a head-to-head study comparing the triplet regimen of belantamab mafodotin, bortezomib, and dexamethasone (BVd) against the standard-of-care triplet of daratumumab, bortezomib, and dexamethasone (DVd) in patients with RRMM who had received at least one prior line of therapy.[19]

The results were transformative. The BVd regimen demonstrated a profound and statistically significant benefit across all major efficacy endpoints:

• Progression-Free Survival (PFS): The trial met its primary endpoint, showing that BVd nearly tripled the median PFS compared to DVd: 36.6 months vs. 13.4 months (HR 0.41; 95% CI: 0.31-0.53; p<0.00001).[6]
• Overall Survival (OS): In a planned interim analysis with a median follow-up of 39.4 months, BVd showed a statistically significant 42% reduction in the risk of death compared to DVd (HR 0.58; 95% CI: 0.43-0.79; p=0.00023).[6] The median OS was not reached in either arm, but the projected median OS was 84 months for BVd versus 51 months for DVd.[37]
• Response Depth and Duration: The responses with BVd were also deeper and more durable, with a minimal residual disease (MRD) negativity rate more than double that of DVd (25% vs. 10%) and a median DoR of 40.8 months versus 17.8 months.[34]

The benefit of the BVd regimen was consistent across all key patient subgroups, including those with high-risk cytogenetics and mild-to-moderate renal impairment.[19]

DREAMM-8: Success with a Pomalidomide Combination (BPd)

The DREAMM-8 trial (NCT04484623) evaluated another combination, pitting belantamab mafodotin, pomalidomide, and dexamethasone (BPd) against the standard-of-care triplet of pomalidomide, bortezomib, and dexamethasone (PVd) in patients with RRMM who had received at least one prior line of therapy, including lenalidomide.[18]

This trial also met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS for the belantamab mafodotin-containing regimen. At a median follow-up of 28 months, the median PFS was 32.6 months for BPd versus 12.5 months for PVd (HR 0.49; 95% CI: 0.35-0.68).[39] The benefit was consistently observed across key subgroups, including patients with high-risk cytogenetics and those with lenalidomide-refractory disease.[18]

Table 2: Summary of Key Efficacy Results from the DREAMM Clinical Trial Program

Trial (Patient Population)	Regimen	Comparator	N	Primary Endpoint	Median PFS (months)	HR (PFS)	Median OS (months)	HR (OS)	ORR (%)	≥VGPR (%)
DREAMM-2 (Heavily Pretreated RRMM, ≥3 prior lines)	Belamaf 2.5 mg/kg	N/A	97	ORR	2.9	N/A	N/A	N/A	31	19
DREAMM-3 (RRMM, ≥2 prior lines)	Belamaf 2.5 mg/kg	PomDex	325	PFS	11.2 vs 7.0	1.03	21.2 vs 21.1	1.14	41	25
DREAMM-7 (RRMM, ≥1 prior line)	BVd	DVd	494	PFS	36.6 vs 13.4	0.41	NR vs NR	0.58	83	66
DREAMM-8 (RRMM, ≥1 prior line, len-exposed)	BPd	PVd	302	PFS	32.6 vs 12.5	0.49	NR vs NR	0.71	77	N/A

Abbreviations: Belamaf, belantamab mafodotin; PomDex, pomalidomide + dexamethasone; BVd, belantamab mafodotin + bortezomib + dexamethasone; DVd, daratumumab + bortezomib + dexamethasone; BPd, belantamab mafodotin + pomalidomide + dexamethasone; PVd, pomalidomide + bortezomib + dexamethasone; N, number of patients; PFS, progression-free survival; HR, hazard ratio; OS, overall survival; ORR, overall response rate; VGPR, very good partial response; NR, not reached; N/A, not applicable.

Data Sources:.1

Ongoing and Future Studies

The clinical development of belantamab mafodotin continues to expand into earlier lines of therapy and new patient populations. The DREAMM-9 study (NCT04091126) is a Phase I dose-optimization trial evaluating belantamab mafodotin in combination with bortezomib, lenalidomide, and dexamethasone (VRd) in newly diagnosed, transplant-ineligible patients, with a focus on exploring less intensive dosing schedules to improve tolerability.[41] The

BELLA study (NCT05055063) is a Phase I trial investigating its safety and efficacy in patients with high-risk smoldering multiple myeloma, a precursor condition.[42] Numerous other trials are actively exploring belantamab mafodotin in various novel combinations and clinical settings, aiming to further define its role in the comprehensive management of multiple myeloma.[42]

Safety, Tolerability, and Risk Management

The clinical use of belantamab mafodotin is intrinsically linked to the management of its distinct safety profile, which is dominated by a novel and frequent ocular toxicity. A comprehensive understanding of this risk, coupled with a structured management strategy, is essential for its safe and effective administration.

Ocular Toxicity: A Defining Challenge

The most common and clinically significant adverse event associated with belantamab mafodotin is ocular toxicity, specifically a form of keratopathy characterized by changes in the corneal epithelium.[14] This is considered the dose-limiting toxicity of the drug.

• Pathophysiology: The keratopathy is an "on-target, off-tumor" effect attributed to the cytotoxic MMAF payload.[13] The cornea's epithelial cells are highly proliferative, and it is hypothesized that these cells can take up the ADC, leading to the same microtubule disruption and cell death seen in myeloma cells. This results in the formation of microcyst-like epithelial changes (MECs), which are aggregates of degenerating epithelial cells visible on a slit-lamp examination.[13]
• Clinical Presentation and Incidence: Patients may experience symptoms such as blurred vision, dry eyes, photophobia (light sensitivity), foreign body sensation, and eye irritation.[1] In more severe cases, it can lead to significant decreases in visual acuity and, rarely, corneal ulcers.[3] Keratopathy is extremely common, reported in approximately 71-77% of patients in the DREAMM-2 trial.[13] Grade 3 or 4 keratopathy (based on examination findings and/or changes in vision) occurred in 31% of patients in one study, though rates of permanent discontinuation due to ocular events in the combination trials were low (≤9%) with appropriate management.[6] A critical aspect of this toxicity is that MECs can be detected on an eye exam even in patients who are asymptomatic, underscoring the necessity of routine ophthalmologic monitoring.[9]
• Management Strategy: The management of ocular toxicity is proactive and protocol-driven, centered on monitoring and dose modification. Prophylactic corticosteroid eye drops have been shown to be ineffective and are not recommended.[13] The key management strategies include:
• Mandatory Ophthalmic Examinations: All patients must undergo a comprehensive eye exam, including visual acuity testing and a slit-lamp examination, at baseline (before the first dose) and prior to each subsequent dose of belantamab mafodotin.[21]
• Supportive Care: Patients are instructed to use preservative-free lubricant eye drops at least four times daily throughout the treatment course to alleviate symptoms of dryness.[21] The use of contact lenses should be avoided.[21]
• Dose Modification: Treatment decisions are guided by the Keratopathy and Visual Acuity (KVA) scale, which grades toxicity based on both examination findings and changes in best-corrected visual acuity (BCVA). Based on the severity, the dose of belantamab mafodotin may be continued, withheld until improvement, or reduced to 1.9 mg/kg.[13]

Table 3: Ocular Toxicity (Keratopathy) Grading and Management Recommendations

Severity (Grade)	Corneal Examination Finding(s)	Change in Best Corrected Visual Acuity (BCVA)	Recommended Action
Mild (Grade 1)	Mild superficial keratopathy	Decline from baseline of 1 line	Continue treatment at current dose.
Moderate (Grade 2)	Moderate superficial keratopathy	Decline from baseline of 2-3 lines (and Snellen acuity no worse than 20/200)	Withhold treatment until improvement to Grade 1 or better. Resume at a reduced dose (1.9 mg/kg).
Severe (Grade 3)	Severe superficial keratopathy	Decline from baseline of >3 lines	Withhold treatment until improvement to Grade 1 or better. Consider permanent discontinuation if unresponsive to management.
Grade 4	Corneal epithelial defect	Snellen acuity worse than 20/200	Consider permanent discontinuation. If continuing, withhold until improvement to Grade 1 or better and resume at a reduced dose.
Corneal Ulcer	Ulcerative keratitis	N/A	Interrupt treatment until the ulcer has healed. Manage promptly with an eye care professional.

Data Sources:.[21]

The BLENREP REMS Program

To ensure the safe use of the drug in light of its significant ocular risk, the FDA mandated a Risk Evaluation and Mitigation Strategy (REMS) program as part of its initial approval.[27] The goal of the BLENREP REMS is to educate healthcare providers and patients about the risk of ocular toxicity and to ensure that appropriate monitoring is performed.[47] The program has stringent requirements for all parties involved:

• Prescribers and Healthcare Facilities: Must be certified in the REMS program, which involves completing training and knowledge assessments.
• Patients: Must be enrolled in the REMS program by their certified prescriber and must be counseled on the risks and the mandatory eye exam schedule.
• Dispensing and Administration: The healthcare facility must obtain authorization from the REMS program before dispensing each dose. This authorization serves as a verification that the patient is enrolled and that the required ophthalmic exam has been completed and reviewed.[47]

Following the U.S. market withdrawal in 2022, new patient enrollment in the REMS program was halted. However, a compassionate use program was established to allow patients already receiving treatment to continue accessing the medication.[4]

Other Clinically Significant Adverse Events

Beyond ocular toxicity, belantamab mafodotin is associated with several other common and clinically significant adverse events.

• Hematologic Toxicity: Myelosuppression is common. Thrombocytopenia (low platelet count) is the most frequent Grade 3 or 4 non-ocular adverse event, occurring in 20-33% of patients in monotherapy trials and up to 56% in the BVd combination trial.[1] Anemia and neutropenia are also frequently reported Grade 3 or 4 events.[1] Regular monitoring of complete blood counts is required, with dose delays or reductions implemented for severe cytopenias.[21]
• Infusion-Related Reactions (IRRs): These reactions, which can include symptoms like fever, chills, and shortness of breath, occur in over 20% of patients.[9] They are typically manageable by interrupting the infusion, providing supportive care, and administering premedication for subsequent infusions.[9]
• Other Common Adverse Events: Other frequently reported adverse events (≥20%) include nausea, pyrexia (fever), fatigue, and diarrhea.[1]
• Embryo-Fetal Toxicity: Belantamab mafodotin can cause fetal harm. Consequently, females of reproductive potential must use effective contraception during treatment and for at least 4 months after the final dose. Male patients with female partners of reproductive potential must use effective contraception during treatment and for at least 6 months after the final dose.[9]

Table 4: Common and Serious Adverse Events (Grade ≥3) in Pivotal Combination Trials

Adverse Event	DREAMM-7: BVd (%)	DREAMM-7: DVd (%)	DREAMM-8: BPd (%)	DREAMM-8: PVd (%)
Keratopathy/Corneal Events	34	3	43	0
Decreased Visual Acuity	22	2	27	2
Thrombocytopenia	56	35	45	39
Anemia	13	16	27	24
Neutropenia	19	33	31	50
Pneumonia	12	4	9	7
Diarrhea	7	4	11	9
Fatigue	5	1	6	4

Data Sources: Data compiled and synthesized from DREAMM-7 and DREAMM-8 trial reports.[6] Note: Rates reflect Grade ≥3 events. Keratopathy for DVd and PVd arms were low as it is not a known toxicity of those agents. Rates for BPd/PVd are from primary analyses and may differ slightly from updated reports.

This comparative safety data highlights that while ocular toxicity is unique to the belantamab mafodotin arms, the addition of the drug to standard backbones also increases the rate of certain hematologic toxicities, such as thrombocytopenia. However, these risks were deemed manageable within the context of the profound efficacy benefits observed in the trials.

The Global Regulatory Journey: A Tale of Two Agencies

The regulatory history of belantamab mafodotin is one of the most dynamic and complex in recent oncology, marked by swift initial approvals, equally swift reversals, and an eventual comeback. The diverging and later converging paths taken by the FDA in the U.S. and the EMA in the E.U. provide a fascinating look into regulatory decision-making in the face of evolving clinical data.

United States (Food and Drug Administration)

• August 2020: Accelerated Approval. Riding a wave of enthusiasm for its novel mechanism and promising data in a difficult-to-treat population, the FDA granted belantamab mafodotin Breakthrough Therapy Designation, Priority Review, and ultimately, Accelerated Approval. The approval was for its use as a monotherapy in adult patients with RRMM who had received at least four prior therapies.[27] This approval was explicitly contingent upon the successful completion of a confirmatory trial to verify its clinical benefit.[28]
• November 2022: Market Withdrawal. The landscape changed dramatically with the results of the DREAMM-3 trial. Because the study failed to meet its primary endpoint of superior PFS versus an active comparator, it did not fulfill the conditions of the Accelerated Approval. Consequently, the FDA requested that GSK withdraw the drug from the U.S. market, and the company complied, initiating the withdrawal process on November 22, 2022.[3]
• 2024-2025: A Pending Comeback. Armed with the overwhelmingly positive data from the DREAMM-7 and DREAMM-8 combination trials, GSK submitted a new Biologics License Application (BLA) to the FDA.[6] However, the path to re-approval has been challenging. In July 2025, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit-risk profile of the proposed combinations, citing persistent concerns over the high rates of ocular toxicity and uncertainties about whether the dosing had been fully optimized to mitigate this risk.[25] The FDA subsequently extended its review period, setting a new action date of October 23, 2025, to allow time to review additional information submitted by GSK.[23] The final regulatory fate of belantamab mafodotin in the U.S. remains uncertain.

European Union (European Medicines Agency)

• August 2020: Conditional Marketing Authorization. Similar to the FDA, the EMA granted a conditional marketing authorization for belantamab mafodotin monotherapy in August 2020 for the same heavily pretreated patient population, based on the DREAMM-2 data. It was also granted orphan drug designation due to the rarity of multiple myeloma.[1]
• February 2024: Non-Renewal of Authorization. Following the DREAMM-3 results, the EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the monotherapy no longer outweighed its risks. As a result, the conditional marketing authorization was not renewed, and it officially expired in February 2024.[5]
• July 2025: Full Marketing Authorization for Combinations. In a remarkable turnaround, the EMA’s view shifted decisively with the availability of the DREAMM-7 and DREAMM-8 data. In May 2025, the CHMP issued a positive opinion, recommending approval for the combination regimens.[6] On July 24, 2025, the European Commission granted full marketing authorization for belantamab mafodotin in combination with bortezomib and dexamethasone (for patients with ≥1 prior therapy) and in combination with pomalidomide and dexamethasone (for patients with ≥1 prior therapy, including lenalidomide).[6] This decision signaled a strong regulatory endorsement of the drug's benefit-risk profile in the combination setting.

Approvals in Other Regions

Concurrent with its re-evaluation in the U.S. and E.U., belantamab mafodotin combinations have secured approvals in several other major markets, including the United Kingdom, Japan, Canada, and Switzerland, further solidifying its global standing as a new standard of care.[6]

Table 5: Global Regulatory Milestones for Belantamab Mafodotin

Date	Regulatory Body	Action	Basis / Indication
Aug 5, 2020	U.S. FDA	Accelerated Approval	Monotherapy for RRMM (≥4 prior lines), based on DREAMM-2
Aug 25, 2020	EMA	Conditional Marketing Authorization	Monotherapy for RRMM (≥4 prior lines), based on DREAMM-2
Nov 22, 2022	U.S. FDA / GSK	Market Withdrawal Initiated	Failure of DREAMM-3 confirmatory trial
Feb 23, 2024	EMA	Authorization Expired (Non-renewal)	Benefits no longer outweighed risks post-DREAMM-3
May 23, 2025	EMA (CHMP)	Positive Opinion	Combination therapies (BVd, BPd), based on DREAMM-7 & -8
July 24, 2025	European Commission	Full Marketing Authorization	Combination therapies (BVd, BPd) for RRMM (≥1 prior line)
July 2025	U.S. FDA (ODAC)	Negative Vote on Benefit-Risk	Combination therapies; concerns over ocular toxicity/dosing
Oct 23, 2025	U.S. FDA	New PDUFA Action Date	Review of BLA for combination therapies is ongoing

Data Sources:.[3]

The divergent paths taken by the FDA and EMA post-DREAMM-3, particularly the FDA's more cautious stance on re-approval, illustrate differing regulatory philosophies regarding risk tolerance. The EMA appears to have concluded that the profound efficacy demonstrated in DREAMM-7 and -8—especially the overall survival benefit—clearly justifies the manageable, albeit serious, ocular toxicity. The FDA's advisory committee, in contrast, placed a heavier weight on the uniqueness and frequency of the ocular toxicity, questioning whether the benefit-risk balance was favorable at the proposed doses. This underscores a fundamental tension in drug regulation: determining the level of toxicity that is acceptable in exchange for a given magnitude of efficacy. The final FDA decision will be a landmark in defining this balance for ADCs with novel toxicity profiles.

Discussion: Place in Therapy and Future Perspectives

The evolution of belantamab mafodotin from a promising but ultimately failed monotherapy to a highly effective combination agent has secured its place as a cornerstone therapy in the management of relapsed and refractory multiple myeloma. Its journey offers critical lessons in drug development and highlights both its established role and its future potential.

Synthesizing the extensive data from the DREAMM program reveals a clear benefit-risk profile for the approved combination regimens. The ocular toxicity, while a significant management challenge that necessitates a dedicated, multidisciplinary approach involving both hematology-oncology and ophthalmology, is largely manageable and reversible with proactive monitoring and adherence to dose modification guidelines.[6] The low rates of treatment discontinuation due to eye-related side effects in the pivotal combination trials attest to the success of this management strategy.[6] When weighed against the substantial and statistically significant improvements in progression-free survival and, most importantly, overall survival, the benefit-risk calculus for belantamab mafodotin combinations is strongly positive for patients with RRMM.[34]

In the contemporary treatment landscape, the belantamab mafodotin combinations (BVd and BPd) are positioned as new, highly effective standards of care for patients at or after the first relapse. The head-to-head superiority demonstrated in DREAMM-7 against a daratumumab-based triplet and in DREAMM-8 against a bortezomib-based triplet establishes these regimens as key options in this setting.[34] As the only approved ADC targeting BCMA, it offers a mechanistically distinct approach compared to other BCMA-directed therapies, such as CAR T-cell therapies (e.g., idecabtagene vicleucel, ciltacabtagene autoleucel) and bispecific antibodies (e.g., teclistamab, elranatamab).[6] Furthermore, its "off-the-shelf" availability and suitability for administration in both academic and community oncology settings provide a crucial logistical advantage over the complex, centralized, and time-consuming manufacturing process required for autologous CAR T-cell therapy.[6]

Despite its established role, several important questions remain, which will be the focus of future research:

• Optimal Sequencing: The proliferation of effective BCMA-targeting agents raises the critical question of optimal sequencing. It is currently unknown how prior exposure to a BCMA-directed CAR-T or bispecific antibody might impact the efficacy of subsequent treatment with belantamab mafodotin, and vice versa. The potential for antigen escape, where myeloma cells downregulate BCMA expression after targeted therapy, is a key concern that requires further investigation.[53]
• Long-Term Safety: While short-term ocular toxicity is manageable, the long-term consequences of chronic, low-grade corneal changes in patients who remain on therapy for extended periods are not yet fully understood.
• Dose Optimization: Although the combination trial schedules have improved tolerability, the search for the absolute optimal dose and schedule to maximize the therapeutic index is ongoing, as evidenced by the exploratory cohorts in the DREAMM-9 study.[41]
• Expansion into Earlier Lines of Therapy: The most exciting future direction is the investigation of belantamab mafodotin in earlier stages of the disease. Trials in newly diagnosed patients (DREAMM-9) and even in the precursor stage of high-risk smoldering myeloma (BELLA study) have the potential to fundamentally alter the treatment paradigm for multiple myeloma if they prove successful.[41]

In conclusion, the clinical and regulatory odyssey of belantamab mafodotin is a paradigm of resilience and data-driven evolution in modern oncology. Initially defined by its unique ocular toxicity and a confirmatory trial failure, it has been successfully redefined through rigorous clinical science that demonstrated its profound life-extending benefits when used intelligently in combination therapies. Belantamab mafodotin has now secured a firm and vital role as a standard-of-care for relapsed/refractory multiple myeloma, offering a potent, mechanistically distinct, and broadly accessible treatment that provides new hope for patients. Its story provides invaluable lessons on the importance of trial design, proactive risk management, and the scientific perseverance required to realize the full potential of innovative cancer therapies.

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