Lynzparza’s new tablet formulation gets FDA approval, expanded indication
WILMINGTON, Del. — AstaZeneca and Merck’s Lynzparza (olaparib) tablets were approved by the Food and Drug Administration, as well as given an expanded indication by the regulatory agency.
The tablets are approved as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. Additionally, they were approved for use twice daily, as opposed to the eight-a-day regimen required of Lynzparza’s capsule formulation.
The drug also is now indicated for use in adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy. The patients for this indication are selected for treatment base on an FDA-approved companion diagnostic.
“Physicians have almost three years of clinical experience with Lynsparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women,” AstraZeneca EVP global medicines development and chief medical officer Sean Bohen said. “Today’s approvals validate more than 10 years of dedicated research behind Lynzparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings. It builds on our recently-announced collaboration with Merck, which aims to further increase the number of treatment options available to patients.”