FDA approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for adult patients with unresectable hepatocellular carcinoma.
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 issued marketing denial orders for several e-cigarette products currently marketed by Logic Technology Development LLC.
Nicole Gormley has been named the acting associate director for Oncology Endpoint Development in the FDA Oncology Center of Excellence. She will also continue her role as the division director for the Division of Hematologic Malignancies 2.
FDA issued a final guidance, “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.”
FDA issued a draft guidance, “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.”
FDA issued a draft guidance, “Tissue Agnostic Drug Development in Oncology.”
The findings from the 2022 National Youth Tobacco Survey on e-cigarette use among U.S. youth, published by FDA and CDC in Morbidity & Mortality Weekly Report, show that youth use of e-cigarettes remains high, with 2.5 million (9.4%) of the nation’s middle and high school students reporting current e-cigarette use.
FDA has granted accelerated approval to Lytgobi (futibatinib) for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 gene fusions or other rearrangements.
The FDA Oncologic Drugs Advisory Committee voted down three problematic indications of cancer drugs, two of which got on the market under the agency’s accelerated approval program.
