AstraZeneca and Merck & Co. announced Monday that the FDA approved Lynparza (olaparib) for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The companies noted that the drug is the only PARP inhibitor authorised in this indication.
The approval comes shortly after an advisory committee voted 7 to 5 to recommend clearance of Lynparza as maintenance treatment for adults with pancreatic cancer. Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, remarked "Lynparza is now the only approved targeted medicine in biomarker-selected patients with advanced pancreatic cancer."
The FDA's decision was based on data from the Phase III POLO trial, with results showing that Lynparza nearly doubled the time patients with germline BRCA-mutated metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months for placebo. Based on findings from the study, the National Comprehensive Cancer Network (NCCN) guidelines were updated in July to recommend Lynparza as maintenance treatment for germline BRCA-mutated pancreatic cancer.
The companies noted that patients will be selected for Lynparza based on Myriad Genetics' FDA-approved companion diagnostic BRACAnalysis CDx, which detects the presence of a BRCA1 or BRCA2 gene mutation. Roy Baynes, Merck's chief medical officer, added that the clearance of the PARP inhibitor "supports the value of germline BRCA testing in patients with this disease."
Lynparza is currently approved for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. The drug is also cleared for the first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy and for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy. The PARP inhibitor, which generated sales of $847 million in the first nine months of 2019, is being jointly developed by AstraZeneca and Merck as part of a deal signed in 2017.
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