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AstraZeneca Gains Priority FDA Review for Breast Cancer Drug

AstraZeneca's Lynparza is for patients who already have been treated with chemotherapy, before or after surgery.
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Pharmaceutical titan AstraZeneca  (AZN) - Get Astrazeneca PLC Sponsored ADR Report said Tuesday that the U.S. Food and Drug Administration has granted priority review for its drug Lynparza used to treat breast cancer after chemotherapy.

“AstraZeneca’s supplemental New Drug Application (NDA) for Lynparza (olaparib) has been accepted and granted Priority Review [by the Food and Drug Administration] for the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery,” the Anglo-Swedish company said.

Lynparza is for patients who already have been treated with chemotherapy, before or after surgery. The application is based on results from a Phase 3 study in which Lynparza produced statistically significant improvement in invasive, disease-free survival.

AstraZeneca and Merck  (MRK) - Get Merck & Co., Inc. Report agreed four years ago to jointly develop and commercialize Lynparza for numerous types of cancer.

“Breast cancer is now the most diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020,” according to AstraZeneca.

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AstraZeneca noted that nearly 91% of all breast cancer patients are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5% of patients.”

Lynparza already has been approved in the U.S., EU, Japan and several other countries for treatment of patients with germline BRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy.

In the EU, this indication also includes patients with locally advanced breast cancer.

The news didn’t do much for AstraZeneca stock, which recently traded at $55.47, down 0.11%, in line with the S&P 500’s 0.25% dip.

AstraZeneca has climbed 11% year to date, but slid the same percentage amount in the last month.