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Next major regulatory approval for DATROWAY outside the U.S. by end of 2025?
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Official announcements from regulatory agencies like EMA or PMDA
Story
FDA Grants Priority Review for KRAS-Mutant Ovarian Cancer Drug; DATROWAY Approved, Daiichi Sankyo Stock Rises 8%
Jan 20, 2025, 05:20 AM
The U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the new drug application (NDA) of avutometinib plus defactinib, aimed at treating patients with recurrent low-grade serous ovarian cancer, particularly those with KRAS mutations. This follows the recent authorization of a breast cancer treatment developed by AstraZeneca and Daiichi Sankyo, which marks the first U.S. approval for this closely watched therapy. The drug, known as DATROWAY, has been approved for patients with previously treated metastatic hormone receptor-positive, HER2-negative breast cancer. Following this approval, Daiichi Sankyo's stock rose over 8%, reflecting investor optimism about the drug's potential in the market.
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