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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 web page for more information.
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, our names are Joseph Wynne and Nicole Sunseri, and we joined FDA Oncology in 2020.
What is your educational and professional background?
Joe grew up in Stony Brook, NY, and majored in Biological Engineering at Cornell University. Nicole grew up in San Jose, CA, and Knoxville, TN, and majored in Microbiology at University of California Davis. They both joined the MD/PhD program at NYU School of Medicine, which is where they met. For his graduate work, Joe worked in a Ras biology lab that investigated how subcellular localization of small GTPases affects their function. Nicole did her graduate work in a virology lab investigating the identification and function of intrinsic myeloid proteins that inhibit HIV infection.
After medical school, they moved to Chicago for residency and fellowship at the University of Chicago Medical Center. Joe was on the adult side (Internal Medicine residency and adult hem/onc fellowship) and Nicole on pediatric side (Pediatric residency and peds hem/onc fellowship). Following residency, they were both instructors in the U Chicago AYA clinic after fellowship. Joe’s research during fellowship and instructorship investigated a novel approach to reprograming cancer cell metabolism to induce new therapeutic susceptibilities in preclinical models of breast cancer and leukemia. Nicole’s research during fellowship and instructorship investigated the effectiveness of targeting the immune checkpoint receptor TIGIT +/- PD1 blockade in preclinical lymphoma models.
What motivated you to join FDA Oncology?
As physician scientists, we were both well versed with the idea of bench to bedside but realized that at the completion of our formal training, we didn’t quite understand why so many promising ideas presented at translational cancer research talks failed to yield viable treatments. It was also around this time that we became aware of the interesting role that FDA clinical reviewers play throughout the drug development process. Ultimately, the combination of learning about drug development and approval process, while serving the public interest for our leukemia and lymphoma patients all within a collegial academic multidisciplinary environment, proved to be too tempting of an offer to pass up.
What do you like to do for fun?
We have three kids who keep us quite busy outside of work. When we are not exploring the DMV area with them, Joe likes to run, bike, and engross himself in sci-fi stories. Nicole likes to stay active with Pilates and read the latest historical fiction novels while cuddling with her cats.
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 and Truth
Myth: Oncology drugs approved under accelerated pathways are not rigorously evaluated.
Answer: Incorrect! Drugs approved under accelerated pathways must undergo post-market studies to confirm their clinical benefit, and the FDA can withdraw approval if these studies fail. For more information, check out Project Confirm.
Have a regulatory question? Send us your questions at projectsocrates@fda.hhs.gov, with the subject line “OCE PULSE Question.”
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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!
March 22, 2024: Mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.
March 21: Safety labeling changes for fluorouracil injection regarding the risk of serious adverse reactions related to fluorouracil use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.
March 19: Ponatinib with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL). Accelerated approval.
March 7: Zanubrutinib with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Accelerated 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 full list of FDA oncology approvals online.
Recent FDA Oncology Publications
Correlations of response rate and progression-free survival with overall survival in immunotherapy trials for metastatic non-small-cell lung cancer: an FDA pooled analysis – Lancet Oncology.
Efficacy of Poly(ADP-ribose) Polymerase Inhibitors by Individual Genes in Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer: A US Food and Drug Administration Pooled Analysis. Journal of Clinical Oncology.
Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a U.S. FDA pooled analysis. Journal of the National Cancer Institute
A Pooled Analysis of Treatment-Free Survival in Advanced Renal Cell Carcinoma. Clinical Cancer Research
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