Clovis submits NDA, MAA for rociletinib

Clovis Oncology Inc. (NASDAQ:CLVS) submitted an NDA to FDA and an MAA to EMA for rociletinib ( AVL-301) to treat non-small cell lung cancer (NSCLC) in patients who have the EGFR T790M mutation and have been previously treated with an EGFR-targeted therapy.

Partner Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN) plans to submit a supplemental PMA for a companion diagnostic that builds upon its FDA-approved therascreen EGFR Mutation Detection Kit RGQ, which has been established for 21 EGFR mutations including T790M. Qiagen and Clovis did not respond to inquiries. ...