FDA Approves Return of GSK's Multiple Myeloma Drug Blenrep

The Food and Drug Administration (FDA) has granted approval for the return of GSK's multiple myeloma drug Blenrep, marking a significant turnaround for a medication that was withdrawn from the U.S. market just three years ago. The decision comes with specific conditions and represents a notable development in the treatment landscape for multiple myeloma patients.

Conditional Approval and New Indications

The FDA's approval for Blenrep's reintroduction comes with mixed conditions. The agency has cleared the drug for use in combination with a regimen involving Velcade, another myeloma medicine. However, it did not approve its use in combination with Pomalyst, as GSK had requested.

Additionally, the FDA has limited Blenrep's use to patients whose multiple myeloma has returned or hasn't responded after at least two prior lines of therapy. This is a more restricted indication compared to GSK's request for approval after one prior line of therapy.

Clinical Data and Competitive Landscape

The approval is based on data from the DREAMM-7 trial, which demonstrated significant improvements in patient outcomes. The Blenrep-Velcade regimen reduced the risk of death by half and tripled median progression-free survival compared to a commonly used three-drug regimen.

Despite these positive results, Blenrep faces a more competitive market than during its initial launch. Cell therapies are now used earlier in patient treatment courses, and multiple bispecific drugs have become available. However, GSK highlights Blenrep's unique advantage as the only BCMA-targeting drug that can be administered across various healthcare settings, including community centers where most multiple myeloma patients receive care.

Regulatory Journey and Future Outlook

Blenrep's path to reapproval has been complex. Initially approved in 2020 as the first marketed multiple myeloma medicine targeting BCMA, it was voluntarily withdrawn from the market in 2022 after failing a confirmatory trial. GSK persisted with testing Blenrep in earlier lines of care and in combination with other standard myeloma drugs, leading to successful trials that supported approvals in the UK, Europe, and Japan.

The U.S. approval process faced challenges, including an FDA advisory panel vote in July that initially found the drug's benefit-risk balance unfavorable. However, GSK's continued efforts and the drug's potential to address unmet needs in multiple myeloma treatment have ultimately led to this new approval.

As Blenrep returns to the market, its performance will be closely watched by the industry, healthcare providers, and patients alike. The drug's ability to provide effective treatment options while managing its known side effects, particularly eye toxicity, will be crucial to its success in this new phase of its lifecycle.