Astellas - Seagen's PADCEV Wins Full FDA Approval And Expanded Label In Tough-To-Treat Urothelial Cancer - Astellas Pharma (OTC:ALPMY), Astellas Pharma (OTC:ALPMF)

The FDA granted full approval and a label expansion for Seagen Inc SGEN - Astellas 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.

Market News and Data brought to you by Benzinga APIs

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

Comments

Popular Channels

Tools & Features

Partners & Contributors

About Benzinga