AstraZeneca PLC, AZN, AZN.L, ZEG.DE, AZN.ST, FDA Calendar, PDUFA Date

Company Name	AstraZeneca PLC AZN, AZN.L, ZEG.DE, AZN.ST
Drug Name	PADCEV (sBLA)
Event Name	FDA decision on PADCEV plus KEYTRUDA for patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy
Event Date	04/07/2026
Outcome Date	11/21/2025
Outcome	FDA approved KEYTRUDA plus Padcev for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy on Nov.21, 2025
Drug Status	Seagen and Astellas entered clinical collaboration agreement with Merck to evaluate combination of Seagen's and Astellas' PADCEV and Merck's KEYTRUDA in patients with previously untreated metastatic urothelial cancer.
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