FDA accepted the supplemental Biologics License Application of Enhertu (fam-trastuzumab deruxtecan-nxki), a HER2-directed antibody drug conjugate, for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.
