The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations.
The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The FDA will consider the committee’s recommendation as it finalises its review on Blenrep ahead of the 23 July 2025 PDUFA date.
Also Read: UK Becomes First Country To Authorize Blenrep In Two Combo Regimens
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.
GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma.
Ahead of the meeting, the FDA staff released a document highlighting key issues of high rates of ocular toxicity, including keratopathy (changes in the corneal epithelium) and visual acuity changes, and poor tolerability seen with each regimen and the resulting uncertainty regarding the appropriateness of the proposed dosages of belantamab mafodotin.
Despite differences in the belantamab mafodotin dosing regimens evaluated in DREAMM-7 and DREAMM-8, there were high rates of ocular toxicity in both trials.
Most patients experienced Keratopathy and Visual Acuity (KVA) events, including high-grade events (all grades: 92% and 93% and Grade 3-4: 77% and 78%, in DREAMM-7 and DREAMM-8, respectively).
The majority of patients (70% in DREAMM-7 and 72% in DREAMM-8) experienced recurrent ocular toxicity events (median of 3 Grade 2 or higher KVA events).
Over 50% of patients (58% in DREAMM-7 and 57% in DREAMM-8) had ongoing Grade 2 or higher KVA events at the data cut-off.
In both trials, there were high rates of dose modifications due to KVA events and recurrent KVA events. The majority of patients (76% in DREAMM-7 and 78% in DREAMM-8) had at least one dose modification due to a KVA event.
The document noted that the corneal toxicity seen with belantamab mafodotin is a unique risk to this product and is not seen with currently available therapies for multiple myeloma.
In May, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Blenrep for adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide.
An approval decision by the European Commission is expected in the third quarter of 2025.
In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
Price Action: At the last check Friday, GSK stock is trading lower by 1.86% to $35.79 during the premarket session.
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