FDA approves Blenrep for relapsed or refractory multiple myeloma
Treatment may be used in combination with dexamethasone, Velcade
The U.S. Food and Drug Administration (FDA) has approved GSK‘s Blenrep (belantamab mafodotin) for adults with relapsed or refractory multiple myeloma.
The approval covers the use of Blenrep in combination with dexamethasone and Velcade (bortezomib) in myeloma patients who have received at least two prior lines of treatment, including a proteasome inhibitor and an immunomodulatory agent.
“Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients,” Tony Wood, chief scientific officer at GSK, said in a company press release. “There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse and re-treating with the same mechanism of action often leads to suboptimal outcomes. We believe Blenrep can redefine treatment for patients with multiple myeloma in all parts of the world, and we are accelerating its development in earlier lines of therapy to support its use across all stages of this difficult-to-treat cancer.”
Blenrep’s prescribing information comes with a boxed warning for eye toxicity. The treatment can cause changes to the cornea — the clear front part of the eye that helps focus light — that may lead to vision problems such as blurred vision, dry eyes, or, in some cases, corneal ulcers and infections. Patients need regular eye exams before starting treatment, before each dose, and should be seen if any new or worsening symptoms appear.
GSK said it worked with the FDA to make Blenrep available through a “new, streamlined” Risk Evaluation and Mitigation Strategy program that will help healthcare providers ensure safe and proper use by streamlining forms and improving communication with eye care specialists. The company will also offer an optional support program, Together with GSK, to all U.S. patients prescribed Blenrep.
Antibody aims to kill cancer cells
Myeloma is a type of blood cancer caused by the uncontrolled growth of plasma cells, a type of immune cell, in bone marrow. When the disease returns after treatment or does not respond to therapy, it is said to be relapsed or refractory.
Blenrep contains an antibody targeting a myeloma cell protein called BCMA attached to a toxic molecule called auristatin F. The antibody is designed to deliver the toxic molecule directly to cancer cells, killing them.
“As the only anti-BCMA agent that can be administered across healthcare settings, including in community centres where 70% of patients receive care, Blenrep fulfils a major patient need,” Wood said.
Blenrep was conditionally approved as a standalone myeloma treatment in the U.S. and the European Union. But the therapy was pulled from both markets after results from the Phase 3 DREAMM-3 clinical trial (NCT04162210) indicated that Blenrep alone was not significantly better than standard-of-care therapies.
GSK pivoted to developing Blenrep for use as part of combination treatments in myeloma. The company’s application seeking FDA approval of two treatment combos — Blenrep together with dexamethasone and Velcade or dexamethasone and Pomalyst (pomalidomide) — was based on data from the Phase 3 trials DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623). Findings from these studies indicated that the Blenrep combos were better than standard of care treatments at reducing the risk of disease progression or death, and the safety profile of the combinations was consistent with the known safety profiles of each individual drug.
Following these results, these two Blenrep combinations were approved by regulators in the U.K., Japan, Canada, and most recently in the EU. But the therapy’s fate in the U.S. remained uncertain, especially after GSK announced that an FDA advisory committee had voted against the benefit/risk profile of these Blenrep combinations.
”Patients urgently need more effective treatment options that can offer more quality time with their loved ones. We see the potential for Blenrep in combination to help patients achieve this.”
The FDA was originally expected to announce its final decision earlier this year, but the agency extended its review to allow time to go over additional information. With this approval, Blenrep is authorized in the U.S. for use in combination with dexamethasone and Velcade only.
“With the approval of Blenrep, we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited,” said Sagar Lonial, MD, chief medical officer at Emory University’s Winship Cancer Institute. “This approval marks an important advance in the US relapsed/refractory treatment landscape.”
Data from the DREAMM clinical trial program will be submitted to the National Comprehensive Cancer Network this year, the company said, a key step toward potential inclusion in treatment recommendations.
GSK is also continuing its DREAMM clinical program to explore Blenrep’s benefits in earlier treatment stages, with data expected in early 2028.
“The reality for most patients with multiple myeloma is a relentless cycle of remission and relapse, as their disease becomes refractory to treatments,” said Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation and the Multiple Myeloma Research Consortium. “Patients urgently need more effective treatment options that can offer more quality time with their loved ones. We see the potential for Blenrep in combination to help patients achieve this.”
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