GSK Discusses FDA's Stance on Multiple Myeloma Drug Blenrep at ASH

At the American Society of Hematology annual meeting in Orlando, Florida, GSK's global head of oncology, research and development, Hesham Abdulla, discussed the FDA's recent approval of their multiple myeloma drug Blenrep.

GSK has reintroduced Blenrep to the market three years after it was voluntarily withdrawn following the failure of a confirmatory study required for its accelerated FDA approval. While regulators in Europe and other countries have approved Blenrep for second-line multiple myeloma therapy, the FDA has restricted its approval to third-line treatment or later.

Abdulla explained that the FDA's different perspective on the benefit-risk balance influenced their decision. The Phase 3 study DREAMM-7 showed positive overall survival data, but further data from the second Phase 3 study, DREAMM-8, is still maturing.

GSK is actively collecting clinical data to support efforts for expanding Blenrep into earlier lines of treatment. Abdulla emphasized the company's enhanced understanding of Blenrep's risks, particularly eye toxicity, and mentioned the streamlined Risk Evaluation and Mitigation Strategy, or REMS, designed to ease the burden on patients and healthcare providers.

As of now, Blenrep is available to patients in the U.S., with GSK having dosed its first patients and planning to continue gathering survival data from ongoing studies. Abdulla noted that a significant portion of multiple myeloma patients are treated in community settings, highlighting the need for accessible treatment options amidst competing therapies like CAR T-cell therapies and bispecific antibodies.