Published on August 27, 2020
FDA Approves Blenrep for Treating Advanced Myeloma
The FDA has granted accelerated approval to Blenrep (belantamab mafodotin-blmf), a first-in-class treatment for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.
How is Blenrep Used to Treat Multiple Myeloma?
Blenrep is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world, according to Dr. Hal Barron, chief scientific officer and president of research and development at GlaxoSmithKline, the manufacturer of Blenrep.
BCMA is a protein that is a target for many therapies.
“This is a target that is also on all myeloma cells, but instead of just attacking any cell that has it, [Blenrep] actually delivers a toxic payload,” said Dr. Joshua Richter of The Tisch Cancer Institute at Mount Sinai Medical Center in an interview with Patient Power Co-Founder Andrew Schorr earlier this month. “This antibody-drug conjugate attaches to the cancer cell and injects a poison directly into the cancer cell that we call MMAF.”
What is Multiple Myeloma?
Multiple myeloma is the second most common blood cancer in the United States and is generally considered treatable, but not curable, according to the American Society of Clinical Oncology (ASCO). In the U.S., more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease, ASCO reports.
Multiple Myeloma Clinical Trial Leads to FDA Approval
The August 5 approval of Blenrep was based on six-month primary results from the DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had exhausted treatment options.
Treatment with single-agent Blenrep 2.5 mg/kg every three weeks achieved a 31% overall response rate in patients who had received a median of seven prior lines of treatment, including an immunomodulatory drug such as Celgene’s Revlimid (lenalidomide), a proteasome inhibitor such as Takeda’s Velcade (bortezomib) and Johnson & Johnson’s anti-CD38 antibody Darzalex (daratumumab).
“One thing that our patients may be happy about is the drug is approved without dexamethasone (Decadron),” Dr. Richter said. “So, steroids are the ultimate double-edged sword of myeloma. Some people love them. Some people hate them, but especially people who've gone through multiple rounds of therapy. It's nice to now have an option that can treat myeloma without the need for concomitant steroids.”
Promising New Treatments for Multiple Myeloma
Blenrep is the latest in a series of multiple myeloma treatments approved by the FDA. In May, the FDA approved daratumumab and hyaluronidase-fihj (DARZALEX FASPRO) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. Two months prior, the agency approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies.
In the DREAMM-2 study, Blenrep was well tolerated. The most reported adverse side effects (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, fever, infusion-related reactions, and fatigue.
“Lots of hope for this new target, because every time we get a new class of drugs in myeloma, it's not simply one new therapy, it's many new therapies,” Dr. Richter said. “So, when Darzalex was approved, we were able to then combine it with drugs like lenalidomide (Revlimid) and pomalidomide (Pomalyst). And for those people where that was inappropriate, we can combine them with drugs like Velcade. And what we're excited about with bela-maf is its ability to combine with other drugs.”
To learn more, watch Belantamab mafodotin (Blenrep) FDA approved for Multiple Myeloma.
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Note: Blenrep is only available through Blenrep Risk Evaluation and Mitigation Strategy (REMS). For more information, call 1-855-209-9188.
- Multiple Myeloma: Statistics
- FDA approves GSK’s BLENREP (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma
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