Rucaparib for Advanced BRCA–Mutated Ovarian Cancer Granted FDA Priority Review

Rucaparib for Advanced BRCA–Mutated Ovarian Cancer Granted FDA Priority Review

The US Food and Drug Administration (FDA) has recently granted priority review to Rucaparib for the treatment of patients with advanced ovarian cancer who have germline or somatic BRCA–mutated tumors. Rucaparib was granted FDA’a Breakthrough Therapy Designation for this indication in April 2015.

The therapy by Clovis Oncology is an oral, small-molecule PARP inhibitor developed for the treatment of platinum-sensitive ovarian cancer, specifically in patients with tumors that have BRCA mutations and other DNA deficiencies commonly referred to as “BRCA-like”.

The FDA’s priority review designation allows advanced ovarian cancer patients who have been previously treated with two or more lines of platinum-based therapy to receive rucaparib treatment. The FDA’s filing decision is expected for Feb. 23, 2017.

“The acceptance of the rucaparib new drug application submission represents an important milestone for rucaparib, and for Clovis,” Patrick J. Mahaffy, president and CEO of Clovis Oncology, said in a press release. “There is tremendous need for additional therapeutic options for patients with advanced (BRCA–mutant) ovarian cancer, and we look forward to cooperating with FDA on the rucaparib new drug application review.”

Rucaparib’s effectiveness was evaluated in 106 patients with advanced BRCA-mutant ovarian cancer whose disease progressed after two or more prior chemotherapies. The patients participated in two multicenter, open-label clinical studies (NCT01482715 and NCT01891344). Patient median age was 59.  They averaged three previous chemotherapy regimens.

The efficacy analysis showed an overall response rate of 54%, with a median duration response of 9.2 months. The safety analysis included 377 patients treated with 600 mg of rucaparib twice per day.

The most commonly reported grade 3 or grade 4 adverse events were anemia/decreased or low hemoglobin (25%), fatigue/asthenia (11%), and increased levels of aspartate transaminase and alanine transaminase (11%).

Treatment was discontinued in 8% of the patients because of adverse events related with the treatment.

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry — or whose tumors have — a mutation in theBRCA genes,” principal investigator Dr. Robert L. Coleman, vice chair of clinical research and chair of gynecology at The University of Texas MD Anderson Cancer Center, said in the press release. “Despite the available treatment options, few effective therapies are at our disposal. Thus, the opportunity to treat women with germline or somatic BRCA mutations with rucaparib after two prior lines of platinum-based therapy represents a meaningful step forward for our patients.”

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