Merck announces that the FDA has issued a Complete Response Letter (CRL) regarding the application for accelerated approval of patritumab deruxtecan for the treatment of advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in adults who have received at least two systemic therapies.

This LRC follows issues identified during the inspection of a third-party manufacturing facility, but does not call into question the efficacy or safety data submitted, Merck stresses.

As a reminder, patritumab deruxtecan, an antibody-drug conjugate (ADC) targeting HER3, is being developed by Daiichi Sankyo and Merck.

The companies are working with the FDA and the third-party manufacturer to quickly resolve the issues and make this treatment available to patients.

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