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FDA issued a draft guidance, “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.”
FDA issued a draft guidance, “Tissue Agnostic Drug Development in Oncology.”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.
Jazz Pharmaceuticals plc and Zymeworks Inc.’s subsidiary, Zymeworks BC Inc., entered into an exclusive licensing agreement under which Jazz will acquire development and commercialization rights to Zymeworks’ zanidatamab across all indications in the U.S., Europe, Japan and all other territories except for those Asia/Pacific territories previously licensed by Zymeworks.
