ALPMF - FDA approves new indication for Astellas and Seagen's PADCEV cancer treatment

The U.S. FDA has granted Astellas Pharma ([[ALPMF]]) and Seagen's ([[SGEN]] -0.4%) PADCEV (enfortumab vedotin-ejfv) expanded approval for a new indication to treat certain patients with urothelial cancer.The approval allows for the use of PADCEV for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.The health regulator also decided to convert the drug's accelerated approval status, which it had granted in 2019, to a regular approval."The FDA's decision to convert accelerated approval to regular approval was based on data from the Phase 3 EV-301 trial, which had a primary endpoint of overall survival for patients treated with PADCEV versus chemotherapy," Andrew Krivoshik, Senior Vice President and Oncology Therapeutic Area Head, Astellas said.Chief Medical Officer of Seagen Roger Dansey highlighted that PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial

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FDA approves new indication for Astellas and Seagen's PADCEV cancer treatment