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Home Industry News AstraZeneca and Merck Sharp and Dohme receive US approval for breast cancer drug

AstraZeneca and Merck Sharp and Dohme receive US approval for breast cancer drug

16th January 2018

AstraZeneca and Merck Sharp and Dohme have received US regulatory approval for a new treatment for advanced breast cancer.

Lynparza has been ratified by the US Food and Drug Administration for use in patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy.

Patients with HR-positive forms of breast cancer need to have been treated with a prior endocrine therapy, or be considered inappropriate for endocrine therapy, before they can receive Lynparza. Patients are selected for therapy using a companion diagnostic from Myriad Genetics.

This approval was based on positive findings from the phase III OlympiAD trial, during which Lynparza demonstrated significantly prolonged progression-free survival benefits compared with chemotherapy.

Dave Fredrickson, executive vice-president and head of AstraZeneca's oncology business unit, said: "This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer, and the only PARP inhibitor approved beyond ovarian cancer."

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