Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug

Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug
This story originally appeared on Zacks

Seagen Inc. SGEN and partner Astellas Pharma Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to its an antibody-drug conjugate (“ADC”), Padcev (enfortumab vedotin). The CHMP recommended approval of Padcev as a monotherapy for the treatment of locally advanced or metastatic urothelial cancer in adult patients who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.

Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug – Zacks

The positive CHMP opinion was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in the given patient population. The study had a primary endpoint of overall survival.

The opinion will now be reviewed by the European Commission. If approved, Padcev will become the first ADC authorized for patients with advanced urothelial cancer…

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