Clovis Oncology submits supplemental new drug application for rucaparib as maintenance treatment for patients with platinum-sensitive recurrent ovarian cancer

Clovis Oncology

9 October 2017 - Company plans to file marketing authorisation application in Europe in early 2018 for maintenance treatment indication.

Clovis Oncology announced today that the company has submitted a supplemental new drug application to the U.S. FDA for rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. 

The submission is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.

Read Clovis Oncology press release


Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier