Rubraca is a monotherapy for the treatment of a limited population of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic). If the Clovis product receives a positive opinion from the CHMP, it could become the third PARP inhibitor approved in Europe for patients with ovarian cancer, competing with rivals AstraZeneca and Tesaro. The company announced on Feb. 21, that the CHMP had “communicated a positive trend vote" for the rucaparib MAA, originally submitted during the fourth quarter of 2016. This vote would have come as a relief to the company given that the committee chose not to issue an opinion on the drug at its December 2017 meeting – indeed the CHMP has had four lists of outstanding issues (LoOIs) relating to the product – adopted on Feb, 23, 2018 and in September, November and December last year. [LoOIs can be adopted at the 180-day point in the 210-day-long evaluation procedure (day 120 for products being evaluated under the accelerated assessment mechanism) where the CHMP still has concerns about an application. More than 90% of MAAs have a day 180 LoOI.] Also see "Think Positive: Clovis Confident Of CHMP Okay For Rubraca" - Scrip, 22 February, 2018. In the US, the Food and Drug Administration approved Rubraca in 2016 as a monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for drug. The FDA has since accepted the company’s supplemental new drug application for rucaparib for a second line or later maintenance treatment indication in ovarian cancer. The application has been granted priority review status with a Prescription Drug User Fee Act date of April 6, 2018.

Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications

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