Merck/Daiichi Beef Up Regulatory Position For HER3 ADC

The two drug makers announced topline Phase III results for patritumab deruxtecan in EGFR-mutated NSCLC. The drug was hit by a complete response letter earlier this year.

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The case for the US Food and Drug Administration to make Merck & Co., Inc. and Daiichi Sankyo Co., Ltd.’s HER3-targeting antibody-drug conjugate (ADC) patritumab deruxtecan the first anti-HER3 ADC to win approval got stronger with the announcement of positive Phase III topline results for the drug in advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), after a regulatory setback earlier this year.

The companies said 17 September that the Phase III HERTHENA-Lung02 study showed statistically significant improvement in progression-free survival (PFS) compared...

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