Clovis dropping rociletinib, focusing on rucaparib

Clovis Oncology Inc. (NASDAQ:CLVS) said late Thursday that it expects FDA to issue a complete response letter for an NDA for rociletinib ( CO-1686). The company intends to focus resources instead on its next most-advanced candidate, rucaparib ( CO-338).

Last month, FDA's Oncologic Drugs Advisory Committee voted 12-1 against accelerated approval of rociletinib to treat EGFR-positive non-small cell lung cancer (NSCLC) in patients whose tumors harbor the T790M mutation. ODAC had recommended that FDA wait to decide whether to approve rociletinib until data from the confirmatory Phase III TIGER-3 trial were available. Panel members had encouraged Clovis to whittle the dose arms in the study to just one, and to stratify the trial population based on acetylation status (see BioCentury, April 25). ...