GSK ADRs spike higher, up 5% as FDA extends review of Blenrep

GSK ADRs spike higher, up 5% as FDA extends review of Blenrep

The U.S. Food and Drug Administration (FDA) has extended its review of Blenrep (belantamab mafodotin), manufactured by GlaxoSmithKline (GSK), following the recent advisory committee meeting. The Oncologic Drugs Advisory Committee (ODAC) of the FDA voted against the overall benefit-risk profile of Blenrep at the proposed dosage for its use in combination with bortezomib and dexamethasone, as well as with pomalidomide and dexamethasone. This decision has led to a 5% increase in GSK's adverse reaction (ADR) reports [1].

The ODAC's decision was based on the committee's assessment of the benefits versus risks of Blenrep in patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. The committee's vote against the overall benefit-risk profile indicates that the FDA may have concerns about the safety profile of Blenrep, particularly regarding ocular side effects. However, the FDA will still consider the committee's recommendation as it finalizes its review of Blenrep, which is expected to be completed by July 23, 2025 [1].

Despite the FDA-ODAC's decision, the International Myeloma Foundation (IMF) continues to advocate for the approval of Blenrep. The IMF, which brings both the patient voice and the science to the conversation, believes that Blenrep offers an evidence-based path forward for patients who need treatment options. The foundation has highlighted the positive results of clinical trials, such as the DREAMM-7 and DREAMM-8 trials, which demonstrated the efficacy of Blenrep in combination with other therapies. However, the IMF also acknowledges the need for better management of ocular side effects and supports ongoing efforts to mitigate these risks [1].

GSK has expressed confidence in the benefit-risk profile of Blenrep and will continue to work closely with the FDA as it completes its review. The company's stock price has been affected by the FDA's decision to extend the review, with a 5% increase in ADRs reported. However, GSK remains committed to its efforts to develop and bring innovative treatments to patients with relapsed or refractory multiple myeloma [1].

References:
[1] https://www.myeloma.org/international-myeloma-foundation-brings-patient-voice-science-fda-odac-meeting-advocates-blenrepr