ARTICLE | Company News
No advisory panel for Clovis' rucaparib
September 8, 2016 7:00 AM UTC
Clovis Oncology Inc. (NASDAQ:CLVS) gained $3.66 (15%) to $28.01 on Thursday after it said in a regulatory filing that FDA does not plan to hold an advisory committee meeting to discuss the company's NDA for rucaparib ( CO-338).
Last month, FDA granted Priority Review to the application seeking accelerated approval of rucaparib as monotherapy in patients with germline or somatic BRCA-mutated advanced ovarian cancer who have received multiple prior chemotherapies. Rucaparib's PDUFA date is Feb. 23, 2017. ...