AstraZeneca and Merck & Co. said Monday that the FDA granted priority review to a filing seeking approval of Lynparza (olaparib) as a maintenance treatment for patients with newly diagnosed, BRCA-mutated advanced ovarian cancer who are in complete or partial response following first-line standard platinum-based chemotherapy. The agency is set to make a decision on the application in the first quarter of 2019.
According to the companies, this is the first regulatory submission accepted by the FDA for a PARP inhibitor in the first-line maintenance setting for advanced ovarian cancer. The filing is based on results from the Phase III SOLO-1 trial, with data presented last month at the European Society for Medical Oncology (ESMO) congress showing that two-year maintenance therapy with Lynparza led to a 70-percent reduction in the risk of progression or death versus placebo in newly diagnosed patients with advanced ovarian cancer and a BRCA1 or 2 mutation.
Lynparza was initially approved by the FDA for use in women with pre-treated BRCA-mutated advanced ovarian cancer, with the drug's indication expanded last year to include maintenance therapy for women 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. Meanwhile, in January, Lynparza became the first PARP inhibitor approved by the FDA for the treatment of patients with metastatic breast cancer whose disease is associated with a BRCA gene mutation.
AstraZeneca and Merck are jointly developing Lynparza under the terms of a 2017 partnership, with third-quarter sales of the drug more than doubling year-over-year to $169 million. For related analysis, see ViewPoints: Oncology at heart of everything going right at AstraZeneca, and ESMO 2018 Interview: Little to concern Merck & Co. and its kingmaker Keytruda; and much to cheer where Lynparza is concerned.
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