Daiichi and Merck Withdraw Lung Cancer Drug Filing After Survival Data Miss
TL;DR Summary
Merck and Daiichi Sankyo have voluntarily withdrawn their BLA for HER3-DXd, a drug for NSCLC, after phase 3 trial results failed to meet survival endpoints and discussions with the FDA. Despite previous promising data, the drug's development faces setbacks, but the companies remain committed to ongoing research across multiple cancer types.
- Daiichi, Merck pull HER3-DXd filing at FDA after confirmatory trial misses survival endpoint Fierce Biotech
- Merck, Daiichi Sankyo Pull Lung Cancer Filing for ADC, Citing Underwhelming Survival Findings BioSpace
- Survival miss prompts Daiichi, Merck & Co. to pull patritumab deruxtecan filing FirstWord Pharma
- Merck, Daiichi pull US application for 'guided missile' therapy for lung cancer Reuters
- Merck, Daiichi Sankyo scrap FDA application for HER3 ADC after survival miss Endpoints News
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