AstraZeneca, Merck's Lynparza is approved by FDA

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AstraZeneca, Merck's Lynparza is approved by FDA

By Sandra Levy - 12/20/2018
AstraZeneca and Merck have received the Food and Drug Administration’s blessing for Lynparza (olaparib) for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated,(gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

“Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes. In SOLO-1, Lynparza in the first-line maintenance setting reduced the risk of disease progression or death by 70% for patients with BRCAm advanced ovarian cancer. Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission,” executive vice president, head of the oncology business unit at AstraZeneca Dave Fredrickson said.

Lynparza is the first PARP inhibitor approved in first-line maintenance for BRCAm advanced ovarian cancer.

“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. We continue to work in collaboration with AstraZeneca on our overall goal of improving outcomes for patients.” senior vice president and head of global clinical development, chief medical officer Merck Research Laboratories, Roy Baynes said.

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