Daratumumab

FDA Advisory Committee Votes 6-2 in Favor of Daratumumab for High-Risk Smoldering Multiple Myeloma

2 days ago

• The FDA's Oncologic Drug Advisory Committee (ODAC) voted 6-2 that daratumumab (Darzalex Faspro) demonstrates a favorable benefit-risk profile for patients with high-risk smoldering multiple myeloma, potentially offering the first approved therapy for this precursor condition. • The phase 3 AQUILA trial showed daratumumab significantly delayed progression to active multiple myeloma with a 51% reduction in risk of progression or death compared to active monitoring, with 5-year PFS rates of 63.1% versus 40.8%. • Committee members expressed concerns about risk classification accuracy and potential overtreatment, but ultimately determined the benefits outweighed risks for this malignant condition that has an 80% five-year progression risk to symptomatic multiple myeloma.

FDA's Approval of MRD as End Point Transforms Multiple Myeloma Research and Treatment

3 days ago

• The FDA's Oncology Drugs Advisory Committee unanimously approved minimal residual disease (MRD) as an end point for accelerated approval of multiple myeloma therapies in April 2024, potentially reducing trial timelines from 10-15 years to just 3 years. • Pharmaceutical companies have rapidly adapted by implementing MRD as a coprimary end point in new trials and amending existing protocols, with the CEPHEUS trial being the first major study to read out with MRD as a coprimary endpoint. • Researchers are now exploring MRD applications beyond drug approval, including using MRD status to guide treatment decisions, developing improved blood-based detection technologies, and expanding the approach to other hematologic malignancies.

Saudi Arabia Seeks to Localize Insulin and GLP-1 Production Through Novo Nordisk Partnership

11 days ago

• Saudi Industry Minister Bandar Al-Khorayef is visiting Denmark to strengthen pharmaceutical partnerships, with a focus on bringing insulin and GLP-1 production to Saudi Arabia through collaboration with Novo Nordisk. • The initiative is part of a strategic partnership between Novo Nordisk and Saudi Arabia's Public Investment Fund via Lifera, aiming to establish local production capabilities for critical diabetes and obesity medications. • Al-Khorayef's tour included visits to Novo Nordisk's advanced insulin production facilities and the Technical University of Denmark Science Park, highlighting Saudi Arabia's commitment to pharmaceutical technology transfer.

Biocon Reports 15% Revenue Growth in Q4FY25, Launches Fifth Biosimilar in U.S. Market

13 days ago

• Biocon Group reported strong Q4FY25 performance with revenue reaching Rs 4,454 crore, up 15% year-on-year, driven by significant market share gains in biosimilars and new product launches. • The company launched Yesintek™ (ustekinumab-kfce), its fifth biosimilar in the U.S. market, which is witnessing strong physician adoption and broad formulary coverage with potential to benefit 100 million lives. • Four of Biocon's biosimilars have each recorded sales of USD 200 million in FY25, with the company's biosimilars business growing 15% for the full year and serving over 5.8 million patients globally.

Allarity Therapeutics Unveils Novel Predictive Tool for Daratumumab Response in Multiple Myeloma Patients

a month ago

• Allarity Therapeutics has developed a new Drug Response Predictor (DRP®) for daratumumab that can identify multiple myeloma patients most likely to benefit from treatment, as presented at AACR 2025. • The daratumumab DRP® is based on 53 genes associated with treatment sensitivity or resistance, and has demonstrated ability to predict treatment outcomes and survival in clinical samples. • This marks Allarity's first DRP® for an antibody therapy, expanding beyond small-molecule drugs and positioning the company for potential strategic partnerships in precision oncology.

Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu

a month ago

• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care. • Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations. • Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.

Genmab Reports Strong Q1 2025 DARZALEX Sales of $3.24 Billion, Demonstrating Continued Market Dominance

a month ago

• DARZALEX (daratumumab) generated $3.24 billion in global net sales during Q1 2025, with $1.83 billion from U.S. markets and $1.41 billion internationally. • Genmab receives royalties on all worldwide sales of both intravenous DARZALEX and the subcutaneous formulation (DARZALEX FASPRO in the U.S.) through its licensing agreement with Johnson & Johnson. • The strong Q1 performance supports analysts' projections of 15.1% annual revenue growth for Genmab over the next three years, despite the company's stock currently trading at a significant discount to target prices.

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

a month ago

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Optimizing Treatment Strategies for Relapsed Multiple Myeloma: From CAR T-Cell Therapy to Novel Combinations

2 months ago

• CAR T-cell therapy has emerged as a valuable option for multiple myeloma patients after first relapse when they are lenalidomide-refractory, with careful consideration needed for pre-treatment strategies to optimize outcomes. • Experts recommend avoiding BCMA-targeted therapies before BCMA-directed CAR T-cell therapy, as this can lead to lower response rates and progression-free survival, while non-BCMA bispecifics like talquetamab may be effective bridging options. • Selinexor-based combinations, including selinexor/pomalidomide/dexamethasone and selinexor/carfilzomib/dexamethasone, show promising efficacy in heavily pretreated patients with response rates of 50-65% and progression-free survival ranging from 6-15 months.

GSK's Blenrep Secures UK Approval for Multiple Myeloma Treatment in Combination Therapy

2 months ago

• The UK's medicines regulatory body has approved GSK's Blenrep (belantamab mafodotin) in combination with other drugs for multiple myeloma patients whose first treatment failed or caused severe side effects. • This approval marks a significant comeback for Blenrep, which was withdrawn from markets in 2022 after failing to outperform existing treatments when used as monotherapy. • Clinical trials demonstrated Blenrep's combination therapy extended progression-free survival and overall survival compared to standard care regimens, including those based on Darzalex (daratumumab).

DARZALEX® Subcutaneous Regimen Receives CHMP Backing for Newly Diagnosed Multiple Myeloma Treatment

3 months ago

• Johnson & Johnson's DARZALEX® subcutaneous formulation combined with VRd receives positive CHMP recommendation for treating newly diagnosed multiple myeloma patients, regardless of transplant eligibility. • The recommendation is supported by the Phase 3 CEPHEUS study, which evaluated the efficacy of daratumumab-VRd compared to VRd alone in 395 patients with newly diagnosed multiple myeloma. • DARZALEX® has demonstrated significant impact in multiple myeloma treatment, having been used in over 618,000 patients worldwide and currently approved in eight indications.

Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones

3 months ago

• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M). • The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma. • Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.

Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests

4 months ago

• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis. • Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology. • Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access. • These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.

J&J's Carvykti Shows Promise in Earlier Myeloma Treatment

5 months ago

• The CARTITUDE-4 study indicates that Carvykti (ciltacabtagene autoleucel) significantly improves progression-free survival in multiple myeloma patients with 1-3 prior lines of therapy. • Carvykti, a BCMA-directed CAR-T therapy, may soon be used earlier in the treatment pathway, potentially leapfrogging Bristol-Myers Squibb's Abecma. • The study compared Carvykti to standard three-drug regimens, showing a significant benefit that led to unblinding of the trial. • Expansion of Carvykti's use is a key component of J&J's strategy in multiple myeloma, alongside other therapies like Darzalex and bispecific antibodies.

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5 months ago

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Daratumumab Plus VRd Improves Outcomes in Transplant-Ineligible Multiple Myeloma Patients

6 months ago

• The phase 3 CEPHEUS trial demonstrated that adding daratumumab to VRd significantly improved outcomes for transplant-ineligible newly diagnosed multiple myeloma patients. • The quadruplet regimen achieved a 60.9% minimal residual disease (MRD) negativity rate compared to 39.4% with VRd alone, demonstrating a significant increase in treatment depth. • Progression-free survival was also significantly improved with the daratumumab regimen, showing a 43% reduction in the risk of disease progression or death. • These results suggest that daratumumab plus VRd could become a new standard of care for transplant-ineligible multiple myeloma patients, offering improved disease control.

GSK's Blenrep Demonstrates Significant Survival Benefit in Multiple Myeloma Trial, Paving Way for Potential Comeback

6 months ago

• GSK's Blenrep, combined with chemotherapy and a steroid, reduced the risk of death by 42% compared to a standard-of-care treatment in relapsed or refractory multiple myeloma. • The DREAMM-7 trial data showed a projected median overall survival of 84 months for the Blenrep combination versus 51 months for the comparator arm. • Blenrep, an antibody-drug conjugate targeting BCMA, is under regulatory review in multiple regions, potentially offering a new treatment option for myeloma patients. • Despite previous market withdrawal due to a failed trial, Blenrep's new data suggests a possible paradigm shift in treating relapsed or refractory multiple myeloma.

Drug Development Updates