March 26 Quick Takes: ADCs from Astellas-Seagen, Gilead under EMA review; plus Pfizer-Lilly, BrainStorm and Ilya
EMA to review Padcev for urothelial cancer
Astellas Pharma Inc. (Tokyo:4503) and Seagen Inc. (NASDAQ:SGEN) said EMA accepted an MAA for Padcev enfortumab vedotin, an antibody-drug conjugate (ADC) targeting PRR4, to treat locally advanced or metastatic urothelial cancer previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.
Gilead ADC under accelerated review in Europe for TNBC
Gilead Sciences Inc. (NASDAQ:GILD) said EMA has accepted for accelerated review an MAA for sacituzumab govitecan-hziy to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease. The ADC targeting TROP2 is marketed as Trodelvy in the U.S. for metastatic TNBC. ...