New Japan Approvals Include Tafinlar, Tagrisso
This article was originally published in PharmAsia News
The latest batch of drug approvals in Japan includes several novel oncology products, some of which have only recently been launched elsewhere, in a sign that applicants and regulators are trying to speed up local access to important new therapies.
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Following a priority review, Japan has approved AstraZeneca’s Tagrisso for the first-line treatment of inoperable or recurrent EGFR mutation-positive NSCLC, further strengthening the drug’s position in this setting.
Although oncology remained strong, Japanese major says it saw multiple impacts from the pandemic, including on hospital visits and clinical trial recruitment, and has already cut its full-year guidance.
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