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AstraZeneca, Merck obtain FDA OK for new Lynparza indication

Lynparza is now approved as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high risk early breast cancer.

AstraZeneca and Merck have obtained the Food and Drug Administration’s clearance for Lynparza for the adjuvant treatment of patients with germline BRCA-mutated HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

“Today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer. Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed,” Professor Andrew Tutt, global chair of the OlympiA Phase III trial and professor of oncology at The Institute of Cancer Research, London and King’s College London, said. “OlympiA has shown that identifying a BRCA1/2 mutation in women with high risk disease opens the additional option of eligibility for olaparib treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients.”

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“This important approval gives early-stage breast cancer patients in the U.S. with a germline BRCA mutation a new targeted therapy option in the adjuvant setting starting today. Lynparza reduces the risk of disease recurrence in these high-risk patients and now new data confirm it also significantly extends patients’ lives versus placebo,” Dave Fredrickson, executive vice president, oncology business unit of AstraZeneca, said. “These data underline the importance of germline BRCA testing as soon as possible after diagnosis to identify patients that may be eligible for Lynparza.”

“For patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer, who often present with more aggressive disease, today’s approval is an important step forward,” Roy Baynes, senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, said. “Compared to placebo, Lynparza as adjuvant treatment offers these patients the potential to live longer without their cancer recurring. We thank the patients, caregivers and healthcare providers for their participation in the OlympiA trial.”

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Lynparza is approved in the U.S., EU, Japan and several other countries for the treatment of adult patients with gBRCAm, HER2-negative metastatic breast cancer previously treated with chemotherapy and, if hormone receptor-positive, endocrine therapy if appropriate based on results from the Phase 3 OlympiAD trial. In the EU and Japan, this indication also includes patients with locally advanced breast cancer.

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