Approval Triggers Milestone Payment and Royalties on Worldwide Net Sales-
Seattle Genetics, Inc. (SGEN) today announced U.S. Food and Drug Administration (FDA) approval of Polivy™ (polatuzumab vedotin-piiq), which is an antibody-drug conjugate (ADC) targeting CD79b that utilizes Seattle Genetics’ technology. Polivy was developed and will be commercialized by Genentech, a member of the Roche Group. It was approved in combination with bendamustine plus Rituxan® (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Polivy previously received FDA Breakthrough Therapy Designation, and was approved more than two months ahead of the Prescription Drug User Fee Act (PDUFA) action date of August 19, 2019.
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