FDA News

FDA grants priority review to Lynparza as part of ovarian cancer maintenance regimen

The FDA granted priority review to olaparib in combination with bevacizumab as first-line maintenance treatment of women with advanced ovarian cancer, according to the agent’s manufacturer.

The designation applies to use of the agent for women in complete or partial response to first-line platinum-based chemotherapy with bevacizumab (Avastin, Genentech).

The FDA is expected to make a decision on the application in the second quarter of this year.

Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor approved for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, maintenance treatment of women with recurrent ovarian cancer and treatment of women with germline BRCA-mutated advanced ovarian cancer. It also is indicated for treatment of germline BRCA-mutated, HER2-negative metastatic breast cancer, as well as first-line maintenance of germline BRCA-mutated metastatic pancreatic cancer.

The FDA based the newest priority review designation on results of the phase 3 PAOLA-1 trial, which included women with advanced ovarian cancer who achieved complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. Researchers enrolled women regardless of biomarker status or surgical outcome.

Investigators assigned women to standard bevacizumab with or without 300 mg olaparib twice daily as maintenance treatment for newly diagnosed advanced stage III or stage IV high-grade serous or endometroid ovarian, fallopian tube or peritoneal cancer.

Results showed the addition of olaparib to bevacizumab reduced the risk for disease progression or death by 41% (HR = 0.59; 95% CI, 0.49-0.72) and improved median PFS by nearly 6 months (22.1 months vs. 16.6 months).

The safety profiles of olaparib and bevacizumab appeared consistent with prior studies of each agent.

The most common adverse events that occurred more frequently among women assigned the combination included fatigue (53% vs. 32%), nausea (53% vs. 22%), anemia (41% vs. 10%), lymphopenia (24% vs. 9%) and vomiting (22% vs. 11%).

A higher percentage of women assigned olaparib plus bevacizumab experienced grade 3 or higher adverse events (57% vs. 51%), including anemia (17% vs. < 1%), lymphopenia (7% vs. 1%), neutropenia (6% vs. 3%), fatigue (5% vs. 1%), nausea (2% vs. 1%) and leukopenia (2% vs. 1%). A higher percentage of women assigned bevacizumab alone experienced grade 3 or higher hypertension (30% vs. 19%), vomiting (2% vs. 1%) or abdominal pain (2% vs. 1%).

Women assigned the olaparib regimen appeared more than twice as likely to require dose interruptions (54% vs. 24%) or dose reductions (41% vs. 7%), or to discontinue treatment (20% vs. 6%).


The FDA granted priority review to olaparib in combination with bevacizumab as first-line maintenance treatment of women with advanced ovarian cancer, according to the agent’s manufacturer.

The designation applies to use of the agent for women in complete or partial response to first-line platinum-based chemotherapy with bevacizumab (Avastin, Genentech).

The FDA is expected to make a decision on the application in the second quarter of this year.

Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor approved for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, maintenance treatment of women with recurrent ovarian cancer and treatment of women with germline BRCA-mutated advanced ovarian cancer. It also is indicated for treatment of germline BRCA-mutated, HER2-negative metastatic breast cancer, as well as first-line maintenance of germline BRCA-mutated metastatic pancreatic cancer.

The FDA based the newest priority review designation on results of the phase 3 PAOLA-1 trial, which included women with advanced ovarian cancer who achieved complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. Researchers enrolled women regardless of biomarker status or surgical outcome.

Investigators assigned women to standard bevacizumab with or without 300 mg olaparib twice daily as maintenance treatment for newly diagnosed advanced stage III or stage IV high-grade serous or endometroid ovarian, fallopian tube or peritoneal cancer.

Results showed the addition of olaparib to bevacizumab reduced the risk for disease progression or death by 41% (HR = 0.59; 95% CI, 0.49-0.72) and improved median PFS by nearly 6 months (22.1 months vs. 16.6 months).

The safety profiles of olaparib and bevacizumab appeared consistent with prior studies of each agent.

The most common adverse events that occurred more frequently among women assigned the combination included fatigue (53% vs. 32%), nausea (53% vs. 22%), anemia (41% vs. 10%), lymphopenia (24% vs. 9%) and vomiting (22% vs. 11%).

A higher percentage of women assigned olaparib plus bevacizumab experienced grade 3 or higher adverse events (57% vs. 51%), including anemia (17% vs. < 1%), lymphopenia (7% vs. 1%), neutropenia (6% vs. 3%), fatigue (5% vs. 1%), nausea (2% vs. 1%) and leukopenia (2% vs. 1%). A higher percentage of women assigned bevacizumab alone experienced grade 3 or higher hypertension (30% vs. 19%), vomiting (2% vs. 1%) or abdominal pain (2% vs. 1%).

Women assigned the olaparib regimen appeared more than twice as likely to require dose interruptions (54% vs. 24%) or dose reductions (41% vs. 7%), or to discontinue treatment (20% vs. 6%).