BioCentury
ARTICLE | Clinical News

Vargatef nintedanib regulatory update

September 29, 2014 7:00 AM UTC

EMA's CHMP recommended approval of Vargatef nintedanib from Boehringer in combination with docetaxel to treat locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology after first-line chemotherapy. The compound is under Priority Review in the U.S. and under accelerated assessment in the EU to treat idiopathic pulmonary fibrosis (IPF). Boehringer declined to disclose the PDUFA date of the NDA. ...