FDA approves Boehringer's afatinib, companion diagnostic

FDA approved Gilotrif afatinib from Boehringer Ingelheim GmbH (Ingelheim, Germany) as a first-line treatment for metastatic non-small cell lung cancer (NSCLC) in patients with an EGFR mutation as detected by an FDA-approved test. FDA also concurrently approved a PMA from Boehringer's partner Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN) for the companion diagnostic, therascreen EGFR Mutation Kit, to identify patients with EGFR mutation-positive tumors.

The approvals come about two months after FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) to expand the label for Tarceva erlotinib to include first-line treatment in patients with metastatic NSCLC and an EGFR mutation. FDA also approved the cobas EGFR Mutation Test from Roche (SIX:ROG; OTCQX:RHHBY) as a companion diagnostic (see BioCentury Extra, May 14). ...