Seagen : CHMP Confirms Positive Opinion For PADCEV In Metastatic Urothelial Cancer

(RTTNews) - Astellas Pharma and Seagen Inc. (SGEN) said Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval of PADCEV (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.

The CHMP initially adopted a positive opinion of enfortumab vedotin on December 16, 2021, providing its recommendation to the European Commission for a final decision.

The positive opinion from the CHMP will now be reviewed by the European Commission. The European Commission decisions are valid in the European Union Member States, as well as Iceland, Norway and Liechtenstein.

Urothelial cancer is the most common type of bladder cancer and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.