Clovis closer to marketing approval for rucaparib

BOULDER — Clovis Oncology Inc. (Nasdaq: CLVS) received positive news regarding its Marketing Authorization Application for rucaparib tablets.

Medical governing bodies for the European Union have indicated a positive trend vote for the use of rucaparib as a monotherapy for the treatment of certain ovarian cancer patients with a BRCA gene mutation.

The Committee for Medicinal Products for Human Use said it plans on a final vote in March.

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“We are pleased with this positive trend vote and the potential for a formal positive vote on the later-line treatment indication next month, especially for a patient population with a significant unmet clinical need,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a prepared statement. “This potential approval also paves the way to a rapid review and potential CHMP vote for the maintenance indication by year-end in an earlier-line and all-comers population for women with advanced ovarian cancer.”

Pending approval for the treatment application, Clovis said it plans to submit a variation to its marketing application based on data from the third phase of its ARIEL3 clinical trial, which showed rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.

In the event of a negative vote, Clovis said it is prepared to file a new marketing authorization application.

After the positive news regarding its application, Clovis stock is up nearly 8 percent, as of time of publication, to $59.32 per share.