FDA Approves Olaparib for Frontline Maintenance Therapy for Ovarian Cancer


The Federal Drug Administration (FDA) made an exciting announcement this week with the first approval for PARP inhibitors to be used for patients following their initial diagnosis and treatment to reduce the risk of recurrence. The FDA approved the use of the PARP inhibitor olaparib (Lynparza®) for frontline maintenance therapy for advanced epithelial ovarian, fallopian tube, or peritoneal cancer patients with BRCA1 and/or BRCA2 mutations who have had a complete or partial response to their initial platinum-based therapy. The approval is based on the SOLO1 phase III study that showed eligible patients who received two 150mg olaparib tablets twice daily had a 70% reduction in the risk of disease progression or death compared to patients who received placebo.

What this means 

Previously, olaparib and other PARP inhibitors received FDA approval to reduce the risk of recurrence in patients with a partial or complete response to platinum-based chemotherapy in the recurrent disease setting, and as a single agent in patients with inherited BRCA1 or BRCA2 mutations, with three or more prior chemotherapy regimens. The new approval for frontline maintenance means that patients who have had surgery and a complete or partial response to platinum-based treatment after being first diagnosed can be treated with olaparib to reduce the risk of recurrence or delay it significantly. The ovarian cancer community has been long awaiting such news.

Dr. Saul Rivkin, the founder of the Rivkin Center for Ovarian Cancer and PARP inhibitor researcher, says, “This is very exciting! We now have something to reduce the chance of recurrence after the initial diagnosis and treatment! It’s the equivalent of tamoxifen for breast cancer patients.”

Who this will impact

Approximately 20-25% of all women with ovarian cancer have either a germline (in all the cells in their body) BRCA1 or BRCA2 mutation (10-15%) or a somatic (in only the tumor cells) mutation in BRCA1 or BRCA2 (5-10%), so the treatment will impact primary treatment of approximately 1 in 4 to 1 in 5 women with a new diagnosis.

Dr. Dan Veljovich, a gynecologic oncologist and Rivkin Center Board Member, noted, “This data is unprecedented and is the most significant advancement in the treatment of ovarian cancer in my 20 year career in this field. The fact that olaparib delayed recurrence in the women getting this drug by at least 3 years compared to women getting chemotherapy alone is incredibly meaningful for this patient population, and even more exciting is that the survival curve for a woman on Lynparza suggests that this survival benefit may ultimately be found to be even longer than this as we follow these women over time, and there is even the possibility that more women taking this drug will be cured of their disease.”

The future

This exciting development brings much needed hope for improving long-term survival for women affected by this disease. The Rivkin Center is dedicated to continue its support and funding of ovarian cancer research to improve the prevention, detection, and treatment of the disease, including studies on PARP inhibitors.

Learn about PARP inhibitor projects funded by the Rivkin Center here.

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