FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is no longer necessary to ensure that the benefits of these CAR T-cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS.
FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
