AstraZeneca, Merck drug gets approval as pancreatic cancer maintenance

The FDA approved Lynparza for patients with pancreatic cancer after chemotherapy whose tumors harbor a certain genetic mutation.

Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

A drug on the market for several years for certain women with ovarian cancer has received approval in the U.S. for pancreatic cancer.

London-based drugmaker AstraZeneca and Kenilworth, New Jersey-based Merck said Monday that the Food and Drug Administration had approved Lynparza (olaparib) as a maintenance treatment for patients with metastatic pancreatic cancer that harbors or is suspected to harbor a deleterious germline BRCA mutation and whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy. Patients’ mutation status will be determined using a companion diagnostic.

Lynparza, which belongs to a class known as PARP inhibitors, was originally approved in 2014 for BRCA-mutated ovarian cancer and has since received approvals as a maintenance treatment for patients with ovarian, fallopian tube or primary peritoneal cancer who have responded to platinum-based chemotherapy.

“Patients with advanced pancreatic cancer historically have faced poor outcomes due to the aggressive nature of the disease and limited treatment advances over the last few decades,” said Dave Frederickson, executive vice president of AstraZeneca’s oncology business unit, in a statement.

Two other PARP inhibitors have FDA approval: Clovis Oncology’s Rubraca (rucaparib) and GlaxoSmithKline’s Zejula (niraparib), both approved for the same settings of ovarian, fallopian tube and peritoneal cancers as Lynparza. Both drugs are also undergoing clinical trials in BRCA-mutated pancreatic cancer, but their development is at a much earlier stage than Lynparza’s, consisting of Phase I/II and Phase II trials, and largely at academic institutions.

Lynparza’s approval as a maintenance therapy in deleterious germline BRCA-mutated pancreatic cancer was based on results of the Phase III POLO study, which were presented in June at the American Society of Clinical Oncology’s annual meeting and published in The New England Journal of Medicine.

Results showed that patients taking Lynparza had a median 7.4-month improvement in progression-free survival, compared 3.8 months for those taking placebo. After one year, 34% of patients on Lynparza showed no disease progression, compared with 15% of those on placebo, while at two years those figures were 22% and 10%, respectively.

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