FDA approves FoundationFocus CDxBRCA companion diagnostic for use with Rubraca in treating ovarian cancer- Foundation Medicine

The FDA has approved the FoundationFocus CDxBRCA companion diagnostic for use with Rubraca, from Foundation Medicine, which is the first next-generation-sequencing (NGS)-based companion diagnostic approved by the agency in ovarian cancer patients. The NGS test detects the presence of deleterious BRCA gene mutations in the tumor tissue of ovarian cancer patients. If one or more of the mutations are detected, the patient may be eligible for treatment with Rubraca.

Comment: The U.S. FDA has 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 tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.