AstraZeneca Says Lynparza Approved in Japan for Early Breast Cancer
25 August 2022 - 8:48AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Thursday that its Lynparza treatment has
been approved in Japan for the treatment of early breast cancer
after positive Phase 3 results.
The Anglo-Swedish pharmaceutical company said the approval by
Japan's Ministry of Health, Labor, and Welfare offered eligible
patients an effective and targeted treatment which improves
survival and helps prevent the recurrence of cancer.
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, the company said.
In March, Lynparza was approved in the U.S. for treating gBRCAm,
HER2-negative high-risk early breast cancer. In August, the
European Union approved the treatment, including for patients with
locally advanced breast cancer.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
August 25, 2022 02:33 ET (06:33 GMT)
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