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.
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FDA issued a draft guidance, “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.”
FDA issued a draft guidance, “Tissue Agnostic Drug Development in Oncology.”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 Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radioligand therapy, in combination with androgen deprivation therapy with or without androgen receptor pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen-positive, metastatic, castration-resistant prostate cancer who have been treated with AR pathway inhibition and taxane based chemotherapy.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for Libtayo (cemiplimab) as a monotherapy for the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy.
Day One Biopharmaceuticals has entered into a Cooperative Research and Development Agreement with NCI’s Division of Cancer Treatment and Diagnosis, Cancer Therapy Evaluation Program to expand therapeutic research opportunities using DAY101 (tovorafenib).
HOOKIPA Pharma Inc., a company developing a new class of immunotherapies based on its proprietary arenavirus platform, and Roche formed a strategic collaboration and license agreement to develop HB-700 for KRAS-mutated cancers, along with a second undisclosed novel arenaviral immunotherapy. This represents HOOKIPA’s first oncology licensing collaboration.
