AstraZeneca and Merck & Co.'s collaborative PARP inhibitor, Lynparza, has received approval from the U.S. Food and Drug Administration.
“Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleased to bring this important medicine, in a new tablet formulation, to a broader group of women," Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said in a statement. "Today’s approvals validate more than 10 years of dedicated research behind Lynparza, the world’s first PARP inhibitor, which now provides oncologists with the greater flexibility for use in terms of treatment settings.
The Lynparza tablets can now be used as a maintenance treatment for adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer. Specifically, the tablets work on patients whose response to platinum-based chemotherapy has been complete or partial.
“Today’s approval demonstrates that olaparib is an effective option for maintenance therapy for certain ovarian cancer patients, regardless of BRCA status," Dr. Richard Penson, clinical director of Medical Gynecologic Oncology at Massachusetts General Hospital Cancer Center and the primary investigator in the trial, said. "We welcome this news in the ovarian cancer community as more options are important to help us ensure that patients can find a treatment that is right for them."