AstraZeneca's Breast-Cancer Drug Gets Priority Review From FDA
AstraZeneca PLC (AZN.LN) on Wednesday said that the U.S. Food & Drug Administration has granted a priority review to its new drug application for tablets that treat breast cancer.
The FTSE 100-listed pharmaceutical company said that the regulator will review its application by the first quarter of 2018. Lynparza treats patients with germline breast cancer who have been previously treated with chemotherapy.
AstraZeneca said that the application is based on positive results from a phase 3 trial published in the New England Journal of Medicine. Lynparza was approved by the FDA in December 2014 in a capsule formulation.
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(END) Dow Jones Newswires
October 18, 2017 02:51 ET (06:51 GMT)