Timeline of key events in Seattle Genetics

2019-07-01T00:00:00+0000The drug is enfortumab vedotin-ejfv, an antibody drug conjugate. It was given accelerated approval for adult patients with locally advanced or metastatic urothelial cancer who failed to respond to PD1 immune checkpoint therapy or platinum-containing chemotherapy. 2019-12-18T00:00:00+00002019-12-23T00:00:00+0000The application was for use of tucatinib, in combination with trastuzumab and capecitabine, for the treatment of adult patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least two prior anti-HER2 treatment.2020-01-01T00:00:00+0000
Date Event People Places Sciences
July 2019Seattle Genetics and Astellas Pharma submitted application to FDA for accelerated approval of enfortumab vedotin  Seattle Genetics, Astellas PharmaMonoclonal antibodies, Oncology
18 Dec 2019FDA granted accelerated approval for Seattle Genetics drug for advanced urothelial cancer Seattle GeneticsMonoclonal antibodies, Oncology
23 Dec 2019Seattle Genetics submitted New Drug Application to FDA for testing tucatinib in patients with locally advanced or metatastic HER2-positive breast cancer Seattle GeneticsMonoclonal antibodies, Oncology
January 2020Seattle Genetics submitted marketing application for tucatinib to the European Medicines Agency Seattle GeneticsOncology

Jul 2019

Seattle Genetics and Astellas Pharma submitted application to FDA for accelerated approval of enfortumab vedotin

18 Dec 2019

FDA granted accelerated approval for Seattle Genetics drug for advanced urothelial cancer

23 Dec 2019

Seattle Genetics submitted New Drug Application to FDA for testing tucatinib in patients with locally advanced or metatastic HER2-positive breast cancer

Jan 2020

Seattle Genetics submitted marketing application for tucatinib to the European Medicines Agency

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