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Merck, Daiichi Sankyo Seeking FDA Approval for Antibody-Drug Conjugate in EGFR-Mutated NSCLC

NEW YORK – Merck and Daiichi Sankyo on Friday announced that they have submitted an application to the US Food and Drug Administration seeking approval for their antibody-drug conjugate (ADC) patritumab deruxtecan as a treatment for EGFR-mutated non-small cell lung cancer.

The FDA granted priority review to the application, which includes data from the Phase II HERTHENA-Lung01 clinical trial in which 29.8 percent of advanced EGFR-mutated NSCLC patients responded to third- or later-line treatment with the ADC. The 225 patients on the trial had to have received prior treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. The median duration of response was 6.4 months.

Patritumab deruxtecan, also called HER3-DXd, is a HER3-directed ADC developed by Daiichi Sankyo. This past October, Merck inked a deal with Daiichi Sankyo to jointly develop patritumab deruxtecan as well as two other antibody-drug conjugates, ifinatamab deruxtecan and raludotatug deruxtecan. In Japan, Daiichi Sankyo maintains exclusive rights to develop and manufacture these agents.

The FDA will review the application under its real-time oncology review program and is expected to decide whether or not to approve patritumab deruxtecan by June 26, 2024.