GlaxoSmithKline said Wednesday that the European Commission granted conditional approval for the antibody-drug conjugate Blenrep (belantamab mafodotin) for use as monotherapy to treat multiple myeloma in adults. Specifically, the anti-BCMA drug, which was cleared by US regulators earlier this month, is indicated for patients who have received four or more prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Hal Barron, president of R&D at the UK drugmaker, said the EU approval "marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year." He suggested Blenrep "will give patients with limited treatment options access to the first approved anti-BCMA therapy."
The approval is based on data from the 196-patient DREAMM-2 trial, which demonstrated that treatment with single-agent Blenrep, administered as a 2.5 mg/kg dose every three weeks, was associated with an overall response rate of 32%. In addition, the median duration of response was 11 months and median overall survival was 13.7 months.
Meanwhile, the most commonly reported adverse events included keratopathy/microcyst-like epithelial changes, which occurred at a rate of 71%, thrombocytopenia, anaemia, blurred vision events and lymphopenia. In an FDA staff document prior to the US approval, agency reviewers had questioned whether Blenrep's benefits exceeded the potential risk of ocular toxicity seen in DREAMM-2, paying particular attention to the high incidence of keratopathy and noting that the problem of ocular toxicity was "unique" among such treatments.
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