“A new drug application (NDA) has been submitted for rociletinib (CO-1686) as a treatment for patients with EGFR T790M-positive metastatic non–small cell lung cancer (NSCLC) following prior administration of an EGFR TKI, according to a statement from the drug’s developer, Clovis Oncology.
“The NDA was preceded by a breakthrough therapy designation for the potent mutant-selective EGFR inhibitor in May 2014. The application was based on findings from the ongoing phase I/II TIGER-X trial, which were published in The New England Journal of Medicine and updated at the 2015 ASCO Annual Meeting. In patients with T790M-mutant NSCLC by tissue testing (n = 243), the objective response rate (ORR) across all dose levels was 53% and the disease control rate (DCR) was 85%.
“An application for premarket approval (PMA) is anticipated for Qiagen’s therascreen EGFR RGQ PCR Kit as a companion diagnostic (CDx) for rociletinib, according to the statement. The therascreen EGFR test was initially approved in 2013 as a CDx for afatinib (Gilotrif) and recently received a new indication as a CDx for gefitinib (Iressa).”