New Molecularly Targeted Therapeutic Approved for Ovarian Cancer

The newly approved therapeutic is for treating women whose cancers test positive for BRCA1 and BRCA2 mutations with a new genetic test.

The U.S. Food and Drug Administration (FDA) recently announced it had approved a molecularly targeted therapeutic called rucaparib (Rubraca) for women with advanced ovarian cancer linked to a BRCA gene mutation. The agency simultaneously approved a new test called the FoundationFocus CDxBRCA test for detecting cancer-associated BRCA1 and BRCA2 gene mutations.

Rucaparib is intended for patients with advanced ovarian cancer who have already been treated with two or more types of chemotherapy and whose cancer harbors a deleterious BRCA mutation.

The deleterious BRCA mutation can be an inherited mutation or one that was acquired during the patient’s lifetime.

Ovarian cancer is relatively rare. According to the National Cancer Institute (NCI), it accounts for just over 1 percent of all new cancer cases diagnosed in the United States each year. This translates to about 22,280 new cases of ovarian cancer in 2016.

New treatment options are urgently needed for advanced ovarian cancer because most patients diagnosed with ovarian cancer are diagnosed at this stage and the prognosis for these women is poor. The five-year relative survival rate for patients with advanced ovarian cancer is just 29 percent.

According to the FDA announcement, the approvals of rucaparib and FoundationFocus CDxBRCA were based on initial results from two small clinical trials involving a total of 106 patients with advanced ovarian cancer that had worsened despite treatment with two or more types of chemotherapy.

The data showed that 54 percent of the patients who received rucaparib had partial shrinkage or complete disappearance of their tumors for a median of 9.2 months. However, given that the approval centered on response data, rather than overall survival, rucaparib’s manufacturer, Clovis Oncology, is required by the FDA to conduct a study to confirm that the drug improves survival for patients.

Rucaparib is the second in a class of molecularly targeted therapeutics called poly ADP-ribose polymerase (PARP) inhibitors to be approved for treating advanced BRCA-mutant ovarian cancer. The first in the class, olaparib (Lynparza), was approved for this use in December 2014.