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ARTICLE | Company News

Jan. 21 Company Quick Takes: First BCMA-targeted therapy gets Priority Review from FDA; plus Roche-Seattle Genetics, AZ-Merck, Chi-Med

January 22, 2020 1:18 AM UTC

Priority Review for GSK's anti-BCMA therapy in MM
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said FDA granted Priority Review to a BLA for belantamab mafodotin to treat fourth-line relapsed or refractory multiple myeloma in patients who have previously received an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. GSK reported data for the BCMA-targeted antibody-drug conjugate in December, showing that belantamab led to a 31% overall response rate in MM patients who had received a median of seven prior lines of treatment (see "GSK Looks to Expand into MM Subsets").

EC approves Roche ADC for DLBCL
The European Commission granted conditional approval to Polivy polatuzumab vedotin from Roche (SIX:ROG; OTCQX:RHHBY) for relapsed or refractory diffuse large B cell lymphoma patients who aren’t candidates for hematopoietic stem cell transplant. The antibody-drug conjugate is indicated for use in combination with Bendeka bendamustine from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) and rituximab. The decision triggers a milestone payment to Seattle Genetics Inc. (NASDAQ:SGEN)...