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AZ and MSD win FDA priority review for Lynparza in breast cancer

Could become the first PARP inhibitor to be approved in the US for the disease


Breast cancer patients in the US may soon receive a new treatment in the form of Lynparza (olaparib) tablets, after the drug won a priority review from the Food and Drug Administration (FDA).

The PARP inhibitor - co-developed and co-commercialised by AstraZeneca (AZ) and Merck & Co - is under consideration for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy.

Lynparza was first approved in the US as a capsule formulation as maintenance therapy to treat ovarian cancer and if the tablet formulation achieves the same result then the drug will be the first approved PARP inhibitor outside ovarian cancer.

Sean Bohen, executive vice president, global medicines development and chief medical officer, AstraZeneca, said: “This is an important milestone for Lynparza as the PARP inhibitor has shown a significant benefit for patients outside ovarian cancer.”

The FDA granted the status based on the phase III OlympiAD trial in which patients with breast cancer on Lynparza tablets saw a reduced risk of disease progression or death by 42% compared to those on chemotherapy.

Bohen added: “The OlympiAD results mark the first time a targeted therapy shows benefit over the current standard of care for patients with HER2-negative gBRCA-mutated metastatic breast cancer.”

Alongside its maintenance therapy indication, the medicine is indicated for use in adult patients with deleterious or suspected deleterious gBRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

Article by
Gemma Jones

19th October 2017

From: Regulatory



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