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# FDA Approves Rubraca for Some Ovarian Cancers
- URL: https://www.fdaweb.com/fda-approves-rubraca-for-some-ovarian-cancers/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:57:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137605

FDA has given accelerated approval to Clovis Oncology’s Rubraca (rucaparib) to treat women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation, deleterious BRCA, as identified by an FDA-approved companion diagnostic test. An agency [news release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm?ref=fdaweb.com) says the FoundationFocus CDxBRCA companion diagnostic is manufactured by Foundation Medicine.

Some 15-20% of ovarian cancer patients have the BRCA mutation, FDA says. Rubraca is described as a poly ADP-ribose polymerase inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking the enzyme, the release says, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slowing or stopping of tumor growth.

Rubraca’s safety and effectiveness were studied in two clinical trials involving 106 patients with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. Some 54% of participants who received Rubraca in the trials experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months, FDA says.

The drug’s common side effects include nausea, fatigue, vomiting, anemia, abdominal pain, dysgeusia, constipation, decreased appetite, diarrhea, thrombocytopenia, and dyspnea. It is associated with serious risks such as myelodysplastic syndrome, acute myeloid leukemia, and fetal harm.