FDA fast-tracks GSK’s multiple myeloma drug after priority review

pharmafile | January 22, 2020 | News story | Research and Development BCMA, FDA, GSK, Phase 2 Trials, Phase Trials, multiple myeloma, myeloma 

The FDA has fast tracked GlaxoSmithKline (GSK) antibody drug conjugate (ADC) belantamab mafodotin, for the treatment of patients with refractory or relapsed multiple myeloma.

The drug delivers a cytotoxic pharmaceutical agent to myeloma cells expressing the antigen BCMA.

The priority review was based on results from the Phase 2 DREAMM2 trial of the drug. It was published in The Lancet and showed that 97 patients who received the drug at 2.5mg/kg and 99 receiving it at 3.4mg/kg, respectively 31% and 34% achieved a response to therapy. This is was in patients who had exhausted multiple previous treatment options for multiple myeloma and received the drug.

Although it was less than the 60% seen in GSK’s first trial of the drug but this was significant given the patient group was much sicker and harder to treat.

Multiple myeloma is the second most commonly diagnosed blood cancer. It is treatable and typically occurs in the bone marrow.

It is a relatively uncommon cancer, and it is mainly treated with chemotherapy and stem cell therapies. It is estimated that 32,110 adults in the United States were diagnosed with multiple myeloma in 2019, and that 12,960 deaths from this disease occurred.

Conor Kavanagh


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