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Recent and Upcoming Public FDA Oncology Events
In case you missed our October 19, 2023 Conversations on Cancer: Living with Metastatic Breast Cancer, watch it on demand! This was the first joint Conversations on Cancer in collaboration with the European Medicine Agency (EMA) and marks a significant milestone in OCE’s ongoing and long-standing collaborations with EMA and other international regulatory agencies.
November 30, 2023, 11:00 am – 12:30 pm ET: Please save the date for an OCE Conversations on Cancer public panel discussion, “How Biotech Built a Blockbuster Cancer Drug.” Please follow @FDAOncology on X or visit FDA’s public meeting page for forthcoming registration information.
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!
Project Livin’ Label: Listen to the “behind the scenes” discussions of the development and backstory of approved oncology drugs. All are free with 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 Timil Patel and I have been at FDA for about 2 years.
What is your educational and professional background? I grew up in Des Plaines, Illinois, and majored in Philosophy at the University of Illinois. I attended Wake Forest for medical school and completed my internal medicine residency at UT Southwestern followed by hematology/oncology fellowship at Yale.
What motivated you to join FDA Oncology? I learned about a potential career at the FDA after being selected as a participant for the FDA-AACR Oncology Educational Fellowship. I met incredibly smart and dedicated oncologists and scientists working tirelessly evaluating new cancer treatments and I quickly realized that being part of this team meant having tremendous influence to potentially save lives and improve the quality of life for cancer patients.
What do you like to do for fun? I love to follow my hometown Chicago sports teams and taking my kids (age 3 and 1) to the numerous museums around the Washington D.C. area.
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?
QUESTION: The FDA takes cost into consideration when deciding whether to approve a drug or not.
ANSWER: False! The FDA does not take cost into consideration when assessing benefit-risk and does not know how much any drug will ultimately cost. Learn more about how FDA assesses benefit-risk by reading this guidance document.
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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!
October 24: Ivosidenib for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.
October 16: Pembrolizumab with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer.
October 13: Nivolumab for the adjuvant treatment of completely resected stage IIB/C melanoma in patients 12 years and older.
October 11: Encorafenib with binimetinib for adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
Recent FDA Oncology Publications
Read about considerations for Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer!
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