FDA has granted accelerated approval to Elahere for the treatment of adult patients with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing EGFR mutation or anaplastic lymphoma kinase genomic tumor aberrations.
FDA approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for Adcetris.
FDA has been mulling over reliance on real-world evidence for about a decade, keeping it on the edges of the existing approval system that runs on data from conventional clinical trials.
FDA issued a revised draft guidance for industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.”
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.
