19 December 2016 - The U.S. FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 

Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumours have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

The agency approved Rubraca under its accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease or condition based on clinical data showing the drug has an effect on a surrogate (substitute) endpoint that is reasonably likely to predict clinical benefit. The sponsor is continuing to study this drug in patients with advanced ovarian cancer who have BRCA gene mutations and in patients with other types of ovarian cancer. The FDA also granted the Rubraca application breakthrough therapy designation and priority review status. Rubraca also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs intended to treat rare diseases.

Read FDA press release