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(1) FDA action date is Oct 10, 2021 BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020 Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after che...

Published: Feb 10, 2021   - Submission Based on Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 -   BOTHELL, Wash. & COPENHAGEN, Denmark--(BUSINESS WIRE)-- Seagen, Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with di...

Search jobs 11-Feb-2021 Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer Company Announcement Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020 COPENHAGEN, Denmark and BOTHELL, Wash.; Feb 10, 2021 – Genmab A/S (Nasdaq...

Press release content from Globe Newswire. The AP news staff was not involved in its creation.

(1) Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Sarah Cannon Research Institute (Sarah Cannon) announced today that the first patient has been dosed in the first-in-human phase 1 study evaluating DS-6000, a CDH6 directed antibody drug conjugate (ADC), in patients with advanced renal cell carcinoma or ovarian cancer with disease progression following standard treatment. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210202005385/en/ Despite recent advances in targeted treatment, five-year survival rates for both ...