Blenrep Is Now Approved in Canada and Europe for Relapsed/Refractory Multiple Myeloma

Patients living with relapsed or refractory multiple myeloma now have access to a new treatment option in Canada and Europe. Health Canada and the European Medicines Agency (EMA) have approved the use of belantamab mafodotin (Blenrep, GSK) in combination with bortezomib and dexamethasone (BVd), or with pomalidomide and dexamethasone (BPd). This approval applies to adult patients who have received at least one prior line of therapy.

What is belantamab mafodotin?

Belantamab mafodotin is an antibody-drug conjugate (ADC). It combines a targeted monoclonal antibody against B-cell maturation antigen (BCMA), a protein found on myeloma cells, with a chemotherapy agent. This design allows it to directly deliver a cell-damaging compound to myeloma cells while sparing more healthy tissues. It is the first and only anti-BCMA ADC approved for multiple myeloma in Canada and the EU.

Clinical trials that supported the approval

The approval was based on results from two large phase III clinical trials: DREAMM-7 and DREAMM-8. These studies tested belantamab mafodotin combinations against current standard treatment combinations.

In the DREAMM-7 trial, patients who received belantamab mafodotin with BVd had a median progression-free survival (PFS) of 36.6 months, and it also showed a 42% improvement in overall survival, a meaningful result for patients seeking longer remission. 

In the DREAMM-8 trial, patients received belantamab mafodotin with BPd. At the time of analysis, the median PFS was 32.6 months, suggesting a durable benefit, and the overall response rate was 77%. 

Managing side effects

The most common side effects observed in both clinical trials were related to the eyes, including: blurred vision, dry eyes, and other symptoms such as eye irritation or sensitivity to light. These side effects were generally manageable by adjusting the treatment schedule or dosage. 

Other side effects included thrombocytopenia (low platelet counts), diarrhea, fatigue, and infections. 

A new milestone in myeloma care

The approvals in Canada and the EU mark the sixth regulatory approval for belantamab mafodotin worldwide. It represents a shift in how early relapse in multiple myeloma is treated. The therapy offers an effective and accessible option that may help extend remission and survival while fitting into community and academic care settings.

In the United States, the approval of belantamab mafodotin is still uncertain, but HealthTree is hopeful that the U.S. Food and Drug Administration (FDA) will follow suit. Earlier this month, the FDA Oncologic Drugs Advisory Committee  rejected belantamab mafodotin combo therapies. The FDA will take this committee’s rejection into consideration when they make a final decision, but approval of this drug is still possible in the US. 

Read the HealthTree CEO Jenny Ahlstrom’s article on the FDA vote here, where she explains in-depth everything myeloma patients need to know about the recent vote and belantamab mafodotin’s future in the United States. 

Key takeaways

Patients with multiple myeloma typically receive combination therapies at diagnosis. If relapse occurs, having additional treatment options with different mechanisms of action becomes crucial. Belantamab mafodotin offers an outpatient-friendly administration schedule that does not require hospitalization or complex preparation. Because of its unique BCMA targeting, belantamab mafodotin may help slow disease progression even in cases where other therapies no longer work.

Read more about Blenrep news and details of the DREAMM studies in these articles: 

• FDA Advisory Committee Rejects Blenrep Combo Therapies—But a Positive Vote is Possible for Myeloma Patients Seeking New Options
• Moving Belantamab Mafodotin to Newly Diagnosed Myeloma?
• Belantamab Combination May Offer an Alternative to CAR-T for Relapsed/Refractory Myeloma
• A Phoenix Rising as Blenrep Shows Positive Data in Multiple Myeloma

Learn more about multiple myeloma treatment updates and research at the HealthTree News Site!

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