OCE has many free educational programs for hematology/oncology fellows, junior faculty, basic and translational scientists, and anyone interested in learning more about regulatory science and drug development. This includes workshops, fellowships, and webinars. Check out our Project Socrates website for more information!
Project Livin’ Label: Listen to the “behind the scenes” discussions of the development and backstory of approved oncology drugs. All Free with CME credit offered by AACR!
Oncology fellowship program directors: if you are interested in having FDA Oncology speak to your fellows, reach out to us at projectsocrates@fda.hhs.gov!
Recent FDA Oncology Approvals
We recently approved these oncology products – take a look at the product labeling to learn about indications, dosage and administration, adverse reactions, trial design, efficacy results, and much more!
September 14, 2023: FDA approves new and updated indications for temozolomide under Project Renewal.
August 14, 2023: Melphalan/Hepatic Delivery System as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph node, subcutaneous tissue, or long that is amenable to resection or radiation.Regular Approval.
August 14, 2023: Elranatamab-bcmm for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.Accelerated Approval.
August 11, 2023: Niraparib and abiraterone with prednisone for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer. Regular Approval.
look at this website How to Use Product Labeling and find a full list of FDA oncology approvals online!
OCE Spotlight – Get to Know Us!
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