AstraZeneca (GB:AZN) has released an update.
AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application for their TROP2-directed ADC, datopotamab deruxtecan, seeking accelerated approval in the US for treating advanced EGFR-mutated non-small cell lung cancer. This move comes after withdrawing a previous application for a broader patient group, guided by feedback from the FDA. The new application is supported by promising results from various clinical trials, highlighting a pronounced benefit for patients with EGFR mutations.
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