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Bendamustine

Generic Name
Bendamustine
Brand Names
Belrapzo, Bendeka, Treanda, Vivimusta
Drug Type
Small Molecule
Chemical Formula
C16H21Cl2N3O2
CAS Number
16506-27-7
Unique Ingredient Identifier
9266D9P3PQ
Background

Bendamustine is a nitrogen mustard drug indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.

Indication

Bendamustine is indicated for use in the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Associated Conditions
Chronic Lymphocytic Leukemia, Follicular Non-Hodgkin's Lymphoma Refractory, Refractory Hodgkin Lymphoma, Refractory Mantle Cell Lymphoma, Waldenström's Macroglobulinemia (WM), Recurrent multiple myeloma, Refractory indolent B cell non-hodgkin lymphoma

Strategic Sequencing of T-Cell Therapies in Relapsed/Refractory Multiple Myeloma: Expert Guidelines

• CAR T therapy is recommended before bispecific antibodies in RRMM due to its potential for durable and deep responses, according to IMWG and ASCO guidelines. • Bridging therapy selection should be based on disease tempo and prior treatments, with GPRC5D-targeted bispecifics preferred when bridging to BCMA-directed CAR T to avoid antigen overlap. • Treatment decisions for RRMM patients should consider disease progression rate, with rapid progression favoring readily available bispecific antibodies and slower progression allowing time for CAR T manufacturing.

Eagle Pharmaceuticals Secures $69 Million Deal to Monetize BENDEKA Royalties

• Eagle Pharmaceuticals has entered into a $69 million royalty purchase agreement with Blue Owl Capital to sell its royalty interest in BENDEKA, a treatment for chronic lymphocytic leukemia and non-Hodgkin lymphoma. • The non-dilutive capital will be used to repay $52.5 million in existing debt, with remaining proceeds allocated to general corporate purposes and ongoing R&D programs. • Eagle continues to invest in its pipeline, including CAL02 for severe community-acquired bacterial pneumonia and EA 114, a novel formulation of Fulvestrant for hormone-receptor-positive metastatic breast cancer.

Gazyva Shows Significant Improvement in Lupus Nephritis Treatment: Phase III REGENCY Trial Results

• Genentech's Phase III REGENCY trial demonstrates that Gazyva plus standard therapy achieved 46.4% complete renal response in lupus nephritis patients compared to 33.1% with standard therapy alone. • The study, published in NEJM, showed clinically meaningful improvements in complement levels and reductions in anti-dsDNA markers, indicating reduced disease activity and inflammation. • Results were consistent across all patient subgroups, including those with Class IV lupus nephritis and higher baseline proteinuria levels, while maintaining Gazyva's established safety profile.

Third-Generation CAR T-Cell Therapy Shows Promise in Relapsed/Refractory CLL

• A phase 1/2 study of HD-CAR-1, a third-generation CAR T-cell therapy, demonstrates encouraging response rates in heavily pretreated CLL patients. • Six of nine patients (67%) achieved complete remission (CR) three months post-treatment, with 83% showing undetectable minimal residual disease. • With a median follow-up of 27 months, the progression-free survival rate was 30%, and achieving CR correlated with significantly longer PFS (P = .024). • The therapy showed a favorable safety profile, with only one case of grade 3 cytokine release syndrome and no neurotoxicity observed.

Yescarta Demonstrates Durable Response and Long-Term Survival in NHL Patients After Five Years

• A five-year follow-up of the ZUMA-5 trial shows Yescarta maintains durable responses in relapsed/refractory non-Hodgkin lymphoma (NHL) patients, including follicular lymphoma (FL) and marginal zone lymphoma (MZL). • The study reported a median progression-free survival of 62.2 months and a median duration of response of 60.4 months, indicating a potential curative effect for these difficult-to-treat blood cancers. • Over half of the patients were alive at the time of analysis, with many requiring no subsequent therapy, suggesting Yescarta may offer a chance for longer survival without additional treatments. • No new Yescarta-related safety signals emerged during the five-year analysis, reinforcing its manageable long-term safety profile in patients with relapsed or refractory NHL.

Genentech's Gazyva Shows Positive Phase III Results in Lupus Nephritis Treatment

• Genentech's Gazyva met its primary endpoint in a Phase III REGENCY study, demonstrating statistically significant benefits for lupus nephritis patients. • Patients treated with Gazyva plus standard therapy achieved a higher rate of complete renal response at 76 weeks compared to standard therapy alone. • The study also showed statistically significant improvements in secondary endpoints, including reduced corticosteroid use and improved proteinuric response. • Gazyva targets disease-causing B cells, potentially preventing or delaying progression to end-stage kidney disease in lupus nephritis patients.

FDA Approves PEMFEXY® Combination Therapy for Metastatic Non-Small Cell Lung Cancer

• Eagle Pharmaceuticals' PEMFEXY® gains FDA approval for use with pembrolizumab and platinum chemotherapy in metastatic non-squamous NSCLC patients without EGFR or ALK aberrations. • PEMFEXY®, a ready-to-dilute liquid formulation, now holds the same indications as ALIMTA®, offering advantages like eliminating reconstitution steps. • This marks the fifth indication for PEMFEXY®, expanding its role in treating non-squamous NSCLC and mesothelioma, enhancing Eagle's oncology portfolio. • The approval strengthens Eagle Pharmaceuticals' position in the market, providing a valuable treatment option for patients undergoing chemotherapy.
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