Merck: FDA response on patritumab deruxtecan
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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