OCE Oncology News: October - Educational Opportunities for Fellows, Junior Faculty and Scientists

U.S. Food and Drug Administration sent this bulletin at 09/29/2023 10:42 AM EDT

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The OCE Owl

October

Greetings from FDA Oncology

Ever wonder who works in oncology at the FDA? Or what happens behind the scenes?

We are a diverse group of over 100 oncologists and are excited to introduce ourselves, explain what we do, and engage with you!

This newsletter provides a summary of FDA Oncology Center of Excellence (OCE) upcoming public events, educational opportunities, and recent oncology product approvals. Events are free and everyone is welcome to attend — we hope to see you there!

Please share this newsletter with your hematology/oncology fellows, faculty, staff, and anyone interested in learning more about what we do at the OCE!

Upcoming Public FDA Oncology Events

October 4, 2023: Meeting of the Oncology Drugs Advisory Committee – Eflornithine for proposed indication to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma who have completed multiagent, multimodality therapy. Meeting Information.

October 5, 2023: Meeting of the Oncology Drugs Advisory Committee – Sotorasib for the proposed treatment of adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA approved test, who have received at least one prior systemic therapy. Meeting Information.

October 16, 2023: FDA/International Society of Pharmacometrics Public Workshop: Using Modeling and Simulation to Evaluate the Effects of Intrinsic and Extrinsic Factors. Meeting Information. Registration.

October 19, 2023: FDA and the European Medicines Agency present Conversations on Cancer: Living with Metastatic Breast Cancer. 9:30-11 am EST | 3:30-5 pm CEST.

For a full list of our past and upcoming meetings and workshops, check out this website: OCE Meetings and Workshops.

Project Socrates: Educational Opportunities

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.

Interested in learning more? Tune into our FDA Oncology Podcast. You can also take a

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!

May Tun Saung is a medical oncologist and a clinical reviewer on the GI and melanoma team. She has a research interest in cancer immunology. In her spare time, she enjoys taking walks with her husband and son, and visiting countries abroad.

Daniel Lee is a medical oncologist in the GU team, and he is interested in utilizing data science in research. He enjoys practicing ambidexterity and meeting new and old faces at networking events, such as trivia nights.

Recent FDA Oncology Publications

FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the treatment of Patients with Unresectable Hepatocellular Carcinoma.

Researcher Experience and Comfort with Telemedicine and Remote Patient Monitoring in Cancer Treatment Trials.

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer.

Interested in learning more about OCE?

Read our FDA Oncology Center of Excellence (OCE) Annual Report
follow us on Twitter @FDAOncology, or send us an email at FDAOncology@fda.hhs.gov.

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