FDA Approves Return of GSK's Blenrep for Multiple Myeloma Treatment

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for the return of GSK's multiple myeloma drug Blenrep, marking a significant turnaround for a medication that was withdrawn from the U.S. market three years ago. The decision comes with specific conditions and represents a crucial development in the treatment landscape for multiple myeloma patients.

Approval Details and Treatment Regimen

The FDA's approval allows Blenrep to be used in combination with a regimen involving Velcade, another myeloma medicine. However, the agency did not approve its use alongside Pomalyst, another proposed combination therapy. The drug is now indicated for patients whose multiple myeloma has returned or hasn't responded after at least two prior lines of therapy, a more restricted use than GSK had initially requested.

GSK's Chief Scientific Officer, Tony Wood, hailed the decision as a "significant milestone," emphasizing the urgent need for novel therapies in multiple myeloma treatment. Wood noted that nearly all patients with multiple myeloma experience relapse, and re-treating with the same mechanism of action often leads to suboptimal outcomes.

Clinical Trial Results and Competitive Landscape

The approval was based on the results of the DREAMM-7 trial, which demonstrated impressive efficacy for the Blenrep-Velcade combination. The 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 approval in 2020. The multiple myeloma treatment landscape has evolved significantly, with cell therapies now used earlier in patient treatment courses and multiple bispecific drugs 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 Safety Considerations

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 Initially approved in 2020 as the first marketed multiple myeloma medicine targeting BCMA, it was voluntarily withdrawn from the market in 2022 after failing a confirmatory trial. The drug's common association with eye toxicity had also posed challenges to its widespread adoption.

In the intervening period, GSK continued testing Blenrep in earlier lines of care and in combination with other standard myeloma drugs. This strategy led to successful trials and approvals in the U.K., Europe, and Japan. However, the U.S. approval process proved more challenging, with an FDA advisory panel initially voting that the data didn't show a favorable benefit-risk balance.

The current approval suggests that GSK has addressed some of the FDA's concerns, potentially through improved management of side effects. Doctors are now better equipped to manage Blenrep's side effects through dose reductions and eye drops, which may contribute to its safer use in clinical practice.