Clovis: Rubraca approved in U.S. for treatment of BRCA1/2-Mutant, metastatic castration-resistant prostate cancer

Monday May 18, 2020 0 comments Tags: Boulder, Clovis Oncology, Rubraca, Patrick J. Mahaffy

BOULDER -- Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca^® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. 

Clovis said the FDA approved this indication under accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the multi-center, single arm TRITON2 clinical trial.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC.

“Standard treatment options for men with mCRPC have been limited to androgen receptor-targeting therapies, taxane chemotherapy, Radium-223 and sipuleucel-T,” said Wassim Abida, medical oncologist, Memorial Sloan Kettering Cancer Center, and principal Investigator for the TRITON2 study.

“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.”

Clovis said FDA approval for this third indication for Rubraca is based on efficacy data from patients with mCRPC and a deleterious BRCA mutation (germline and/or somatic) enrolled in the multi-center, single arm TRITON2 (NCT02952534) clinical trial.

The most common adverse reactions (greater than or equal to 20% of patients; CTCAE Grade 1-4) occurring in the BRCA mutant population (n=115) were asthenia/fatigue, nausea, anemia, ALT/AST increased, decreased appetite, constipation, rash, thrombocytopenia, vomiting, and diarrhea.

The most common laboratory abnormalities (greater than or equal to 35% of patients; CTCAE Grade 1-4) were increase in ALT, decrease in leukocytes, decrease in phosphate, decrease in absolute neutrophil count, decrease in hemoglobin, increase in alkaline phosphatase, increase in creatinine, increase in triglycerides, decrease in lymphocytes, decrease in platelets, and decrease in sodium.

“The data from the TRITON2 clinical trial supporting the FDA approval of Rubraca in mCRPC have been highly consistent over time, and we are pleased that the FDA has granted an accelerated approval for Rubraca in this third indication,” said Patrick J. Mahaffy, president and CEO of Clovis Oncology.

“We are proud to offer Rubraca as a new treatment option to physicians and eligible prostate cancer patients with a deleterious BRCA mutation beginning today.”

“The FDA approval of Rubraca is a significant milestone for patients with metastatic castration-resistant prostate cancer and a deleterious BRCA mutation,” said Howard Soule, executive VP and chief science officer of the Prostate Cancer Foundation.

“Although new treatments for prostate cancer have been approved in recent years, most men living with advanced stages of this disease continue to face a difficult journey with few treatment options.”

The American Cancer Society estimates nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020.