FDA to review Boehringer's afatinib for NSCLC

Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA accepted and granted Priority Review to afatinib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation as detected by an FDA approved test. Boehringer said the PDUFA date is in 3Q13, but the exact date is not disclosed. An MAA for the dual inhibitor of EGFR and HER2 is also under review for the indication by EMA.

Separately, Boehringer's partner Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN) submitted a PMA to FDA for Qiagen's therascreen EGFR RGQ PCR Kit to identify patients with EGFR mutation-positive tumors. The test is a proposed companion diagnostic for afatinib. A version of the molecular assay combining allele-specific PCR and Scorpions, a rapid fluorescent signaling system, is already approved in the EU and Japan. Qiagen acquired rights to the product through its 2009 acquisition of DxS Ltd. (see BioCentury, Nov. 2, 2009). ...