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

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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