FDA Grants Ovarian Cancer Drug Accelerated Approval

Officials with Clovis Oncology announced today they have received accelerated FDA approval for Rubraca (rucaparib) to treat advanced ovarian cancers.

Rubraca is approved for women who have been treated with 2 or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

The FoundationFocus CDxBRCA companion diagnostic was also approved by the FDA for use with Rubraca. It is the first next-generation-sequencing(NGS)-based companion diagnostic to be approved by the FDA. The NGS test detects the presence of deleterious BRCA gene mutations in the tumor tissue. Rubraca is indicated for treatment in patients in which one or more of these gene abnormalities is present in the tumor tissue.

Rubraca’s approval is based on safety and efficacy results from 2 single-arm clinical trials that included 106 participants with BRCA-mutated advanced ovarian cancer who had been treated with 2 or more chemotherapy regimens. Ninety-six percent of tested trial participants using the FoundationFocus CDxBRCA companion diagnostic exhibited BRCA gene mutations in their tumor tissue. Following the trials, 54% of participants treated with Rubraca experienced complete or total shrinkage of their tumors.

“Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s gene,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence, said in a press release. “Women with these gene abnormalities who have tried at least 2 chemotherapy treatments for their ovarian cancer now have an additional treatment option.”

Adverse effects of Rubraca include nausea, fatigue, vomiting, low red blood cell levels, abdominal pain, unusual taste sensation, constipation, decreased appetite, diarrhea, low blood platelet levels, and trouble breathing. Rubraca is also associated with serious risks such as bone marrow problems, acute myeloid leukemia, and fetal harm.

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