publication date: Jan. 3, 2020

Drugs & Targets

FDA approves Lynparza as first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

FDA approved Lynparza (olaparib) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza. AstraZeneca and Merck sponsor Lynparza.

The approval follows the Dec. 17 recommendation by the FDA Oncologic Drugs Advisory Committee for Lynparza in this indication, and was based on results from the pivotal phase III POLO trial published in The New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology Annual Meeting.

“Today’s approval of olaparib based on the POLO results gives clinicians an important 1st-line maintenance treatment option which nearly doubled the progression-free survival benefit in patients with germline BRCA-mutated metastatic pancreatic cancer,” Hedy L. Kindler, co-principal investigator of the POLO trial and professor of medicine at the University of Chicago Medicine, said in a statement.

Results showed a statistically significant and clinically meaningful improvement in progression-free survival, where Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months vs. 3.8 months on placebo (HR 0.53 [95% CI 0.35-0.81], p=0.0035). The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.

 

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Astellas Pharma Inc. sponsors Xtandi. … Continue reading FDA approves Lynparza as first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer

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