In a letter addressed to FDA Commissioner Robert Califf, Republican leaders of the House Committee on Energy and Commerce and two of its subcommittees raised questions about the increasing number of clinical trials conducted in China by companies seeking FDA approval for “me-too” checkpoint inhibitor drugs.
FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
