BioCentury
ARTICLE | Clinical News

Vintafolide regulatory update

December 3, 2012 8:00 AM UTC

Endocyte and Merck said EMA accepted for review MAAs for conditional approval of vintafolide and companion diagnostic etarfolatide to treat folate receptor-positive platinum-resistant ovarian cancer in combination with pegylated liposomal doxorubicin. The partners said the applications were based on the results from 2 single-arm Phase II trials in ovarian cancer and non-small cell lung cancer and the Phase IIb PRECEDENT trial in patients with platinum-resistant ovarian cancer. EMA's acceptance of the MAAs triggers a $5 million milestone payment from Merck to Endocyte. ...