FDA panel recommends expanding label of AstraZeneca, Merck & Co.'s PARP inhibitor Lynparza to include pancreatic cancer

AstraZeneca and partner Merck & Co. announced Tuesday that an FDA advisory committee voted 7 to 5 to recommend approval for Lynparza (olaparib) to treat certain patients with pancreatic cancer. Specifically, the companies are seeking to have the PARP inhibitor's label expanded to include first-line maintenance monotherapy for patients with germline BRCA-mutated metastatic adenocarcinoma of the pancreas, whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy.

José Baselga, head of oncology R&D at AstraZeneca, noted that "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," adding that the companies "look forward to working with the FDA as it completes the review of our application." The US regulator is expected to render its decision by the end of this year. 

The filing is backed by data from the Phase III POLO trial, in which Lynparza significantly improved progression-free survival versus placebo, reducing the risk of disease progression or death by 47% (for additional analysis, see ViewPoints: ASCO19 - High bar suggests Lynparza has shown enough in pancreatic cancer). 

Aside from the US, where it has orphan drug status, Lynparza is also under review in Europe, Canada and other jurisdictions as a first-line maintenance treatment for patients with germline BRCA-mutated metastatic pancreatic cancer.

Lynparza is currently approved in 65 countries, including the US, for maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status, as well as in the US, EU, Japan and elsewhere for first-line maintenance of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. The drug is also approved in 44 countries, including the US and Japan, for germline BRCA-mutated, HER2-negative metastatic breast cancer previously treated with chemotherapy, and in the EU the label also includes locally advanced breast cancer.

Earlier this year, Clovis Oncology presented Phase III study data demonstrating that its PARP inhibitor Rubraca (rucaparib) produced clinical responses in patients with BRCA- or PALB2-mutated pancreatic cancer who responded to platinum-based chemotherapy.

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