By Joe Hoppe

 

AstraZeneca PLC said Monday that its Lynparza treatment has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use for early breast cancer treatment, after positive Phase 3 results.

The Anglo-Swedish pharmaceutical company said the treatment is the first PARP inhibitor--a type of targeted cancer drug--to improve overall survival in early-stage, high-risk breast cancer.

Lynparza has been recommended for marketing authorization as a monotherapy or in combination with endocrine therapy, specifically for treating adults with germline BRCA1/2 mutations, or gBRCAm, with HER2-negative high-risk early breast cancers that have previously been treated with chemotherapy.

The decision was based on positive results from a trial, published in June 2021. The treatment demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% when compared with a placebo, it said. The drug's safety and tolerability in the trial was also in line with prior results, it added.

The treatment was approved in the U.S. for treating gBRCAm, HER2-negative high-risk early breast cancer in March.

 

Write to Joe Hoppe at joseph.hoppe@wsj.com

 

(END) Dow Jones Newswires

June 27, 2022 02:35 ET (06:35 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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