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Monday, September 20, 2021

Seagen, Genmab: FDA Accelerated Approval for Cervical Cancer Med

 Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to TIVDAK™ (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is approved under the FDA’s Accelerated Approval Program based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

https://www.businesswire.com/news/home/20210920005921/en/Seagen-and-Genmab-Announce-FDA-Accelerated-Approval-for-TIVDAK%E2%84%A2-tisotumab-vedotin-tftv-in-Previously-Treated-Recurrent-or-Metastatic-Cervical-Cancer

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