LONDON (dpa-AFX) - Friday, AstraZeneca PLC (AZN) along with Daiichi Sankyo (DSKYF.PK) announced that Datroway has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer.
The approval comes after Priority Review by the U.S. Food and Drug Administration based on results from the TROPION-Breast02 phase 3 trial, which demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival.
Based on the findings of the trial, Datroway has been included in the NCCN Clinical Practice Guidelines in Oncology as a Category 1 Preferred first-line treatment option.
Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., commented, 'With this approval, Datroway is now approved for three indications in the U.S., including two for breast cancer, underscoring its potential to play an important role across tumor types.'
Currently, AZN is trading at $187.65, down 1.10 percent on the New York Stock Exchange.
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