FDA News

FDA grants priority review to rucaparib for advanced BRCA–mutated ovarian cancer

The FDA granted priority review to rucaparib for the treatment of advanced ovarian cancer in patients with germline or somatic BRCA–mutated tumors.

The designation applies to use of rucaparib (Clovis Oncology) in patients who have undergone two or more lines of platinum-based therapy. The FDA is expected to make a decision on the filing by Feb. 23.

“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 company-issued 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.”

The ARIEL clinical development program evaluated rucaparib in women with advanced ovarian cancer.

The efficacy analysis (n = 106) revealed an overall response rate of 54% (95% CI, 44-64), with a median duration of response of 9.2 months (95% CI, 6.6-11.6).

The safety analysis included 377 patients treated with a starting dose of 600 mg rucaparib twice daily.

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

Eight percent of patients discontinued treatment due to rucaparib-related adverse events.

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry — or whose tumors have — a mutation in the BRCA genes,” principal investigator Robert L. Coleman, MD, vice chair of clinical research and chair in 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.”

The FDA granted priority review to rucaparib for the treatment of advanced ovarian cancer in patients with germline or somatic BRCA–mutated tumors.

The designation applies to use of rucaparib (Clovis Oncology) in patients who have undergone two or more lines of platinum-based therapy. The FDA is expected to make a decision on the filing by Feb. 23.

“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 company-issued 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.”

The ARIEL clinical development program evaluated rucaparib in women with advanced ovarian cancer.

The efficacy analysis (n = 106) revealed an overall response rate of 54% (95% CI, 44-64), with a median duration of response of 9.2 months (95% CI, 6.6-11.6).

The safety analysis included 377 patients treated with a starting dose of 600 mg rucaparib twice daily.

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

Eight percent of patients discontinued treatment due to rucaparib-related adverse events.

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry — or whose tumors have — a mutation in the BRCA genes,” principal investigator Robert L. Coleman, MD, vice chair of clinical research and chair in 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.”