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Recent and Upcoming Public FDA Oncology Events
Project Socrates: Educational Opportunities
FDA Oncology offers free educational programs for anyone interested in regulatory science and drug development. Check out the Project Socrates website for more information!
Check out the latest episode of Project Livin’ Label – fam-Trastuzumab Deruxtecan-nxki: The Backstory! Watch the episode here and read the labeling to receive free CME credit, offered by AACR!
Oncology Fellowship Program Directors: if you are interested in having FDA Oncology speak at your program, reach out to us at projectsocrates@fda.hhs.gov.
Get to Know Us - Why I joined FDA Oncology
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Hi, my name is Jenny Stundon and I joined FDA Oncology in 2023.
What is your educational and professional background? I completed my undergraduate degree in Biology at Bryn Mawr College, and then joined the MD/PhD program at Rutgers/Princeton University. I did my graduate work with Dr. Virginia Zakian, focusing on helicases, telomeres, and G-quadruplexes. After medical school, I went to the Children’s Hospital of Philadelphia (CHOP), where I participated in the accelerated research pathway, combining my pediatric residency and pediatric hematology-oncology training. My research as a fellow in Dr. Roger Greenberg’s lab focused on alternative telomere lengthening and a novel association between alternative telomere lengthening and the mismatch repair pathway. I continued at CHOP as an instructor to complete my research and worked as a pediatric oncology attending. I joined the FDA in September 2023 as a clinical reviewer in the Division of Oncology 3.
What motivated you to join FDA Oncology? As an oncology fellow, I was surprised to learn that despite treatment advances for so many cancers over the past few decades, treatment for patients with sarcoma still relies on traditional cytotoxic therapy, and we are still unable to cure so many of these patients. By joining the FDA, I’m able to help mobilize novel discoveries into safer, more effective treatment for these patients. I’m still very new to the FDA and have been enjoying getting to participate in the lively multidisciplinary discussions about new drugs and learn about how the whole regulatory process works.
What do you like to do for fun? I love hiking, running, and good food. I’m new to the area and live in Baltimore with my husband and two small children. We’ve been exploring the area and enjoying the quirky museums and delicious ice cream here.
Contact FutureofHemeOnc@fda.hhs.gov if interested in job opportunities or to learn about benefits such as loan repayment and Quality of Worklife at FDA.
Myth or Fact?
MYTH: The FDA is slow to approve cancer drugs, causing delays in patient access to potentially life-saving treatments.
FACT: While the FDA's approval process is rigorous, it prioritizes patient safety. The agency expedites the review of promising cancer therapies through various mechanisms, such as Fast Track and Breakthrough Therapy designations and the Accelerated Approval Pathway.
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Recent FDA Oncology Approvals
We've recently approved these oncology products—check the labeling for details on indications, dosages, side effects, trial design, efficacy results, and more!
January 18: Erdafitinib for adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR-3 genetic alterations.
January 12: Pembrolizumab with chemoradiotherapy for patients with FIGO 2014 Stage III-IVA cervical cancer.
December 15: Efortumab vedotin-ejgv with pembrolizumab for adult patients with locally advanced or metastatic urothelial cancer.
December 14: Belzutifan for adult patients with advanced renal cell carcinoma following a PD-1 or PD-L1 inhibitor and a VEGF inhibitor.
Interested in learning more? Tune into our FDA Drug Information Soundcast in Oncology. You can also take a look at this website How to Use Product Labeling and find full list of FDA oncology approvals online.
Recent FDA Oncology Publications
When Less is More – Reducing Complexity in Cancer Trials – Lancet Oncology.
Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests – JAMA Oncology.
The Bar is High: Evaluating Fit-for-Use Oncology Real-World Data for Regulatory Decision Making – JCO Clinical Cancer Informatics.
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