FDA granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA accepted a new drug application and granted priority review designation for the investigational compound sevabertinib (BAY 2927088), an oral, small molecule, tyrosine kinase inhibitor, for the treatment of adult patients with advanced non-small cell lung cancer whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
