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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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Dr. Chatchada Karanes is a hematologist/oncologist in the Division of Hematologic Malignancies 1 and joined FDA Oncology in 2021.
What is your educational and professional background?
I received my medical degree from Ramathibodi medical school in Bangkok, Thailand, and completed a one-year rotating internship there. I then completed internal medicine residency in Evanston, Illinois, followed by hematology-oncology fellowship at Washington University in St. Louis.
During my hematology-oncology fellowship there were only few drugs to treat hematologic malignancies such as vincristine, prednisone, Ara-C. Treatment for solid tumors was even more limited. Therefore, I rotated through NIH/NCI to learn more about new investigative treatments. At that time, hematopoietic cell transplant was the only curative treatment for hematologic malignancies, therefore I decided to do 2-year training in stem cell transplant at Washington University in St. Louis. That became my lifelong career path.
I then spent 20 years at Wayne State University in Detroit, as a faculty in heme malignancies and hematopoietic cell transplantation. There, I had opportunities to be involved in early drug development in leukemia and stem cell transplant and became active in the Southwest Oncology Group. Subsequently, I became a medical director at the National Marrow Donor Program in Minneapolis for 5 years before returning to an academic career at City of Hope Cancer Center in Duarte, CA, until 2021. I continued to be involved in several clinical trials in cord blood expansion, bi-specific antibodies and CAR-T cell therapies for leukemia, lymphoma, and multiple myeloma. I was lucky to be able to treat patients with exciting new therapies that could produce meaningful quality of life.
What motivated you to join FDA Oncology?
I was looking for new opportunities where I could use my experience in clinical trials and drug development. Dr. Richard Pazdur convinced me that working at FDA Oncology would fulfill my desire to continue to be involved in new treatment for cancer patients. At FDA, I continue to learn how to apply regulatory science to new drug development, working closely with different disciplines in reviewing new drug applications.
What do you like to do for fun?
I used to play tennis for fun. As I got older, gardening and cooking have become my daily activities. I also enjoy watching movies, traveling, and learning about different cultures. I've been fortunate to reside in various regions of the United States, which has exposed me to diverse ethnic cultures and cuisines.
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.
True or False?
The FDA is responsible for setting drug prices.
False! The FDA does not consider pricing when making regulatory decisions. The eventual cost and availability of a drug post-FDA approval are not within the FDA's regulatory purview.
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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!
February 16: Osimertinibwith platinum-based chemotherapy for patients with locally advanced or metastatic non-small lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
February 16: Lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
February 15: Tepotinib for adult patients with metastatic non-small cell lung cancer harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
February 13: Liposomal irinotecan with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
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
Hot off the press – the Oncology Center of Excellence 2023 Annual Report! Highlighting OCE’s work in 2023 across FDA oncology and with external stakeholders to advance the development and regulation of oncology products for patients with cancer.
FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit.
Impact of Increasing PD-L1 Levels on Outcomes to PD-1/PD-L1 Inhibition in Patients with NSCLC: A Pooled Analysis of 11 Prospective Clinical Trials.
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