US approves AstraZeneca, Merck & Co.'s Lynparza for first-line maintenance therapy in ovarian cancer

AstraZeneca and Merck & Co. announced Wednesday that the FDA has expanded approval of Lynparza (olaparib) to include maintenance treatment of certain patients with BRCA-mutated ovarian cancer. According to the companies, the decision makes Lynparza the first PARP inhibitor approved in the first-line maintenance setting for the disease. 

Specifically, the expanded label is for adults with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by Myriad Genetics' BRACAnalysis companion diagnostic, which the FDA also approved Wednesday.

Expanded approval for Lynparza was supported by data from the Phase III SOLO-1 trial. Results unveiled in October showed that two-year maintenance therapy with Lynparza cut the risk of disease progression or death by 70 percent versus placebo in newly diagnosed patients with BRCA-mutated advanced ovarian cancer who experienced a complete or partial response to platinum-based chemotherapy. 

Roy Baynes, head of global clinical development and chief medical officer at Merck Research Laboratories, commented that "the expanded approval of Lynparza based upon the SOLO-1 trial has the potential to change medical practice and reinforces the importance of knowing a woman's BRCA status at diagnosis." The FDA granted priority review to the drugmakers' submission of Lynparza for the expanded indication last month. 

Lynparza was first cleared in the US in 2014 for patients with BRCA-mutated advanced ovarian cancer who received three or more prior lines of chemotherapy. The label was later expanded to include maintenance therapy in women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, irrespective of BRCA status. Earlier this year, the PARP inhibitor was also authorised for patients with metastatic breast cancer whose disease is associated with a BRCA gene mutation. 

Sales of Lynparza, which AstraZeneca and Merck agreed to co-develop last year for multiple cancer types, more than doubled in the third quarter to $169 million, and generated $297 million last year. 

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