Posted by Michael Wonder on 30 Dec 2019
Lynparza approved in the US as a first-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer
30 December 2019 - Only PARP inhibitor approved in germline BRCA-mutated metastatic pancreatic cancer.
AstraZeneca and MSD today announced that Lynparza (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) 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.
The approval follows the recommendation from the US FDA Oncologic Drugs Advisory Committee on 17 December 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.
