GSK's Blenrep Faces FDA Scrutiny in Multiple Myeloma Comeback Bid
GSK's antibody-drug conjugate Blenrep (belantamab mafodotin) is facing intense scrutiny from the U.S. Food and Drug Administration (FDA) as the pharmaceutical giant seeks to reintroduce the treatment for relapsed or refractory multiple myeloma. The FDA's concerns, primarily centered on ocular toxicities and dosing issues, come ahead of a crucial advisory committee meeting scheduled for this week.
FDA Flags Safety and Efficacy Concerns
In a briefing document released Tuesday, FDA reviewers expressed reservations about the efficacy and safety profile of Blenrep. While acknowledging that two supporting studies met their primary efficacy endpoints, the agency highlighted "high rates of ocular toxicity and dose modifications" as significant concerns. The FDA noted that these ocular side effects are "unique" and "not seen with any currently available treatments for multiple myeloma."
The regulatory body also questioned the applicability of the trial data to the broader U.S. population, citing limited enrollment of U.S. patients, Black or African American participants, and individuals aged 75 and older in the DREAMM-7 and DREAMM-8 trials.
Blenrep's Rocky Regulatory Journey
Blenrep's path through the regulatory landscape has been tumultuous. The drug received accelerated approval in August 2020 for relapsed or refractory multiple myeloma. However, in November 2022, it failed to demonstrate significant improvement in progression-free survival (PFS) compared to pomalidomide plus dexamethasone in the confirmatory Phase III DREAMM-3 study. Consequently, GSK voluntarily withdrew Blenrep from the U.S. market, and the FDA officially withdrew its approval in February 2023.
Recent Clinical Trial Results Reignite Hope
Despite these setbacks, GSK has presented new data that could potentially revive Blenrep's prospects:
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The Phase III DREAMM-7 trial showed that combining Blenrep with Takeda's Velcade (bortezomib) led to significant PFS benefits in relapsed or refractory multiple myeloma patients.
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Additional DREAMM-7 data indicated that Blenrep outperforms Johnson & Johnson's Darzalex (daratumumab) in the second-line setting.
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The DREAMM-8 study demonstrated Blenrep's superiority over a Velcade-based regimen in terms of PFS and treatment response.
These results have prompted GSK to pursue Blenrep's reintroduction to the market. However, the FDA's latest concerns suggest that the path forward may not be straightforward.
As the pharmaceutical industry awaits the outcome of this week's advisory committee meeting, the future of Blenrep in the treatment landscape for multiple myeloma remains uncertain. The FDA's decision will likely have significant implications for both GSK and patients seeking new options in the fight against this challenging form of blood cancer.
References
- GSK’s Blenrep DREAMMs Turn Fitful as FDA Questions Comeback in Multiple Myeloma
In advance of this week's adcomm, the FDA flags ocular toxicities associated with the antibody-drug conjugate, which received accelerated approval in August 2020 but was pulled from the market two years later after a confirmatory trial failed to improve progression-free survival.
Explore Further
What are the major ocular toxicities identified in the clinical trials for Blenrep?
How do the safety and efficacy results of Blenrep in the DREAMM-7 and DREAMM-8 trials compare to those of its competitors in multiple myeloma treatment?
What specific factors led to the FDA's concern over the trial data's applicability to the broader U.S. population?
What is the potential impact of the advisory committee meeting's outcome on GSK’s strategic plans for Blenrep's market reintroduction?
What are the sales figures and market positions of Blenrep's primary competitors in the treatment of relapsed or refractory multiple myeloma?