Clovis cancer news

Clovis will reduce staff and contractor positions by 35% by year end compared to the end of 2015 and will reprioritize resources from rociletinib to its next most-advanced candidate, rucaparib. Clovis stopped enrollment in all studies of rociletinib, including the confirmatory Phase III TIGER-3 trial, and withdrew an MAA for the compound. The company said it expects FDA to issue a complete response letter for an NDA for rociletinib following last month’s 12 to one vote by FDA’s Oncologic Drugs Advisory Committee (ODAC) against accelerated approval of the candidate 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 TIGER-3 were available (see BioCentury, April 18). At Feb. 22, Clovis had 309 employees.

This quarter, Clovis plans to complete submission of a rolling NDA to FDA for rucaparib as monotherapy in patients with germline or somatic breast cancer early onset (BRCA)-mutated advanced ovarian cancer who have received multiple prior therapies. The oral inhibitor of poly(ADP-ribose) polymerase-1 (PARP-1) and PARP-2 has breakthrough therapy designation from FDA. Clovis said it hopes to launch rucaparib in the U.S. by 1Q17 and expects to complete an MAA submission in 4Q16. Clovis has exclusive, worldwide rights to rucaparib under a 2011 deal with Pfizer Inc. (NYSE:PFE, New York, N.Y.), which received rights from Cancer Research UK (London, U.K.) (see BioCentury, June 6, 2011). ...