2 October 2018 - Breakthrough therapy designation granted to Rubraca based on initial data from on-going TRITON2 Phase 2 study in advanced prostate cancer.

Clovis Oncology announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Rubraca (rucaparib) as a monotherapy treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor (AR)-directed therapy and taxane-based chemotherapy.

The FDA previously granted breakthrough therapy designation to Rubraca for the monotherapy treatment of certain advanced ovarian cancer patients and then in December 2016 approved Rubraca for the treatment of certain adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. The FDA subsequently approved Rubraca in a second indication, the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, in April 2018.

Read Clovis Oncology press release