The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) just days before the drug’s Prescription Drug User Fee Act (PDUFA) date.
This marks a significant setback for the UK-based pharma company, which is aiming to regain approval of the therapy after it was pulled from the US market in 2022 due to concerns raised by late-stage trial data.
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By GlobalDataBlenrep was approved under the FDA accelerated approval process in 2020 to treat multiple myeloma (MM). It is an antibody drug conjugate (ADC) that combines a humanised BCMA monoclonal antibody with the cytotoxic agent auristatin F, linked together by a non-cleavable linker.
The ODAC committee had a 7–1 split against the combination of Blenrep plus pomalidomide and steroid dexamethasone and a 5-3 split against the combination of Blenrep with bortezomib and dexamethasone.
GSK states it remains confident in the benefit/risk profile of Blenrep as a combination therapy and will continue to work closely with the FDA as they complete the review of the drug in patients with relapsed or refractory multiple myeloma (r/r MM).
The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.
The concern of ocular toxicity was first highlighted in a document published ahead of the ODAC meeting that took place on 17 July. The recommendation given by ODACs is usually followed by the FDA when deciding if a drug should be approved.
Data supporting the drug’s approval comes from the DREAMM-7 (NCT04246047) and DREAMM-8 (NCT04484623) studies. In the studies, many patients experienced keratopathy and Visual Acuity (KVA) events. All grade KVAs occurred in 92% and 93% of patients in DREAMM-7 and DREAMM-8, respectively, while more serious grade 3-4 events were found in 77% and 78% of patients in the same two studies.
Blenrep combinations are approved in r/r MM in the UK and Japan, as well as other markets, including Switzerland, based on the results of DREAMM-8. Applications for approval in the European Union (EU) and China are ongoing, based on the results of the DREAMM-7 study.
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