FDA Approves Rubraca for Metastatic Castration-Resistant Prostate Cancer That Expresses a BRCA Gene Mutation

The Food and Drug Administration (FDA) has approved the targeted drug Rubraca (rucaparib) for the treatment of men who have metastatic, treatment-resistant prostate cancer that expresses a BRCA gene mutation and has previously been treated with hormonal therapy and a taxane-based chemotherapy.

The agency gave accelerated approval to the treatment, part of a family of drugs known as PARP inhibitors, for men with metastatic castration-resistant prostate cancer (mCRPC) with a BRCA mutation that is either inherited or acquired.

The approval is based on findings from the ongoing phase 2 TRITON2 trial, in which Rubraca demonstrated a 43.9% confirmed objective response rate in 57 evaluable patients in the target population. Among those with BRCA alterations, 51.1% experienced a meaningful drop in prostate-specific antigen, a substance in blood associated with the aggressiveness of prostate cancer.

“Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, radium-223 and sipuleucel-T,” Dr. Wassim Abida, principal investigator of TRITON2 and a medical oncologist at Memorial Sloan Kettering Cancer Center, stated in a press release. “Rubraca is the first in a class of drugs to become newly available to patients with mCRPC who harbor a deleterious BRCA mutation. Given the level and duration of responses observed with Rubraca in men with (mCRPC) and these mutations, it represents an important and timely new treatment option for this patient population.”

Side effects of any severity that occurred in 20% or more of patients were weakness or fatigue (55.3%), nausea (49.5%), anemia/decreased hemoglobin (37.9%), decreased appetite (27.9%), liver damage (24.7%), constipation (24.7%), vomiting (22.1%) and diarrhea (21.1%).

Rubraca was previously approved to be used alone for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have responded to platinum-based chemotherapy.

It is also approved for the treatment of patients with BRCA mutation-associated epithelial ovarian, fallopian tube or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic of them.

Check back later for what you need to know about this approval.