Lynparza Approved in U.S. as First-line Maintenance Therapy for BRCA-positive Advanced Ovarian Cancer

Lynparza Approved in U.S. as First-line Maintenance Therapy for BRCA-positive Advanced Ovarian Cancer

Women with BRCA-mutated advanced ovarian cancer living in the United States can now receive Lynparza (olaparib), developed by AstraZeneca and Merck, as a maintenance treatment for their partial or complete response to first-line platinum-based chemotherapy.

The U.S. Food and Drug Administration’s decision makes Lynparza the first PARP inhibitor to be approved as a first-line maintenance therapy for BRCA-mutated advanced ovarian cancer.

“Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes,” Dave Fredrickson, executive vice president and head of the oncology business unit at AstraZeneca, said in a press release. “[This] approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

The faster division rate of cancer cells makes them accumulate errors faster than healthy cells. Lynparza, a PARP enzyme inhibitor, was designed to prevent cancer cells from repairing their DNA errors, which eventually causes them to die. The therapy is particularly effective in cancers with mutations in DNA-repairing genes, such as BRCA1 and BRCA2.

Lynparza is currently available in more than 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer, regardless of patients’ BRCA mutation status. It is also used for women with BRCA-mutated advanced ovarian cancer who have been treated with at least three chemotherapy treatments, and as a maintenance therapy for women with BRCA-mutated relapsed ovarian cancer whose tumors responded to platinum-based chemotherapy.

Approved under the FDA’s priority review process, Lynparza’s label extension was supported by clinical data from a double-blinded, multicenter Phase 3 trial (NCT01844986) called SOLO-1.

Still ongoing, the trial enrolled 391 patients with high-grade serous or endometrioid ovarian cancer, primarily peritoneal cancer, or fallopian-tube cancer with a mutation in BRCA1, BRCA2, or both genes.

Interim data after a median follow-up of 41 months showed that 60% of patients on Lynparza were alive, without signs of cancer recurrence or progression for at least three years, compared with 27% of patients receiving a placebo. The findings represented a 70% reduction in the risk of death or disease progression in these patients.

“This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression,” said Kathleen Moore, MD, co-principal investigator of the SOLO-1 trial and associate director for clinical research at Stephenson Cancer Center at The University of Oklahoma.

AstraZeneca and Merck — known as MSD outside North America — are conducting additional studies to continue exploring Lynparza’s potential in treating ovarian cancer. These include the Phase 3 PAOLA-1 trial (NCT02477644) that is studying a combination of Lynparza and Avastin (bevacizumab) as maintenance therapy for patients with newly diagnosed advanced ovarian cancer, regardless of their BRCA status. Top-line results of this study are expected to be announced in the second half of 2019.

“We continue to work in collaboration with AstraZeneca on our overall goal of improving outcomes for patients,” said Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories.

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