Astellas - Seagen's PADCEV Wins Full FDA Approval And Expanded Label In Tough-To-Treat Urothelial Cancer

  • The FDA granted full approval and a label expansion for Seagen Inc SGENAstellas Pharma Inc's ALPMF PADCEV to treat patients with advanced or metastatic urothelial cancer who aren't eligible for cisplatin chemo.
  • PADCEV is now available for second-line patients, and the OK is the first for those who have previously received immunotherapy and cannot receive cisplatin.
  • Seagen and Astellas were granted accelerated approval from the FDA in 2019 to treat patients who'd previously received a PD-1/L1 inhibitor and platinum-containing chemotherapy before or after surgery.
  • The FDA switched its decision to full approval after reviewing data from a Phase 3 (EV-201) trial, Astellas oncology therapeutic area head Andrew Krivoshik said in a press release.
  • The study compared PADCEV to chemotherapy in 608 patients that had previously been treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
  • In the drug arm, patients lived for a median of 3.9 months longer than those who received only chemo.
  • In Cohort 2 of the trial evaluated PADCEV in patients (n=89) who had been previously treated with a PD-1/L1 inhibitor, had not received platinum-containing chemotherapy in this setting and were ineligible for cisplatin.
  • After a median follow-up of 16 months, 51% of patients in the treatment arm had an objective response, with a median duration of response of 13.8 months.
  • The most common side effects included rash, fatigue, peripheral neuropathy, and anemia, among others.
  • Price Action: SGEN closed at $148.50 and ALPMF closed at $16.75 on Friday.
  • Related content: Benzinga's Full FDA Calendar.
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