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Recent and Upcoming Public FDA Oncology Events
February 22, 2024: FDA-IMS Joint Workshop: Defining Patient Populations for Clinical Trials in Multiple Myeloma. Register Here
November 30, 2023, 11:00 am – 12:30 pm ET: Join us for an OCE Conversations on Cancer public panel discussion, “How Biotech Built a Blockbuster Cancer Drug.” Register Here
Watch the recent Oncology Drugs Advisory Committee Meetings (ODAC) discussions for timely completion of confirmatory trials after accelerated approval – with a focus on pralatrexate and belinostat.
In case you missed FDA speakers at the 2023 Friends of Cancer Research Annual Meeting, watch it on demand. Learn about dose-finding in early-phase trials, integrating pragmatic trial elements in oncology drug development, and optimizing the utilization of data from academic-led studies for regulatory decision-making.
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.
Applications for the February 2024 FDA/ASCO Fellows Day Workshop are being accepted until November 27. Apply online here.
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 Geetika Srivastava and I have been at FDA for a year and a half.
What is your educational and professional background? I grew up in New Delhi, India. I attended All India Institute Medical Sciences, New Delhi for medical school. I received my Masters in Public Health from University of Texas, Houston. During that time, I worked at a lab at MD Anderson Cancer Center developing a mouse model for chronic GVHD. I completed my internal medicine residency at University of Arkansas, Little Rock, AR and fellowship in Hematology-Medical Oncology at Mayo Clinic in Rochester, MN. I was then in clinical practice at University of Colorado for almost 8 years prior to joining FDA.
What motivated you to join FDA Oncology? Having received part of my medical training in India and now practicing in US, I have always been impressed by the tremendous impact FDA has not only in the US but also globally in saving lives of cancer patients and ensuring safety and integrity of the drug development process. While I am grateful for the opportunity to care for cancer patients in clinic, I also want to be part of a bigger mission. FDA’s public health footprint and the academic rigor of regulatory review work is something that I find both inspiring and fulfilling.
What do you like to do for fun? I love spending time with my family (husband and 10-year-old daughter). We love to travel, explore new places and stay active. I also enjoy cooking and while our daughter doesn’t quite approve of my cooking, I’d like to believe that I am good at it!
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: Can oncologists who work at FDA still participate in research?
ANSWER: Definitely—you can find approval summaries, pooled analyses, perspectives, and other published manuscripts on the OCE Publications web page.
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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!
November 16: Enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.
November 16: Capivasertib with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
November 16: Pembrolizumab with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
November 15: Repotrectinib for locally advanced or metastatic ROS1-positive non-small cell lung cancer.
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
Read about the first approval for the subset of patients with HER2-positive colorectal cancer - FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.
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