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Upcoming FDA Oncology Events
January 16, 2025: FDA-AACR Workshop: DPD Deficiency and Weighing Potential Harms. 9 am-3 pm ET. In-Person Registration. Virtual Registration.
Hope to see many of you at the 2024 American Society of Hematology (ASH) Annual Meeting and the 2024 San Antonio Breast Cancer Symposium (SABCS). FDA oncology will be participating in several presentations and panel discussions:
ASH:
- Friday, December 6:
- 12:00-5:00 pm PST - Come visit the FDA Blood Booth! ASH-A-Palooza.
- 1:30-2:00, 2:40-3:10, 3:20-3:50 pm PST: Blood Buddies one on one mentoring with FDA Staff. ASH-A-Palooza.
- Saturday, December 7:
- 11:15 am-12:15 pm PST - Career Development Lunch, Government Careers (FDA) Table. Grand Hyatt - Coronado Ballroom
- 4:30-6:30 pm PST – Paper 0387: Feasibility of Multi-Model Physical Function Data Collection to Assess Treatment Tolerability in Patients with Lymphoma. San Diego Convention Center Room 6B
- 5:30-7:30 pm PST – Poster Session
- Paper 1829: Response Rate, Event-Free Survival, and Overall Survival in Higher-Risk Myelodysplastic Syndromes: U.S. Food and Drug Administration Trial-Level and Patient-Level Analyses
- Paper 1907: Novel T-Cell Receptor Signature Linked to Plasma Cell Dyscrasias
- Paper 2416: FDA Analysis of Enrollment of Pediatric and AYA Patients in Clinical Trials by Race and Ethnicity
- Sunday, December 8:
- 6:00-8:00 pm PST – Poster Session – Paper 3806: FDA Analysis of Race and Ethnic Enrollment of Clinical Trials for Drug Registration in Adult Patients for Leukemia and Myelodysplastic Syndrome
- Monday, December 9:
- 10:30 am -12:00 pm PST – ASH-FDA Joint Symposium. Advancing Drug Development for Hematologic Malignancies. San Diego Convention Center - Room 11
SABCS:
- Tuesday December 10:
- 12-1:45 pm CST – FDA Special Session: New Drug Approvals, Location: Stars at Night 3-4
- 2-3:45 pm CST – Clinical Workshop: Dose Optimization in Breast Medical Oncology, Location: Stars at Night 1-2
- 2:30-4 pm CST – Career Development: Patient Driven Protocol Development, Location: Room 221ABC
- Wednesday December 11:
- 5:30-7 pm CST, Poster Session 2 – P2-09-19: Efficacy of cyclin-dependent kinase 4/6 inhibitor + endocrine therapy in patients w/ hormone receptor-positive, HER2-negative advanced or metastatic breast cancer w/ liver or lung only metastases: a US Food & Drug Administration pooled analysis
- Thursday December 12:
- 12-1:30 pm CST – FDA and Patients and Advocates Q&A, Location: Room 211
- Friday December 13:
- 12:30-2 pm CST – The Pathologists Conundrum: IHC Testing in Breast cancer, Location: Room 221ABC
In case you missed it:
November 7, 2024: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. Discussion of the ProSense Cryoablation System will focus on the sponsor’s proposed indication: “for use in the treatment of patients with early stage, low-risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy.”
 Above, in-person participants in the FDA-ASCO Hematology/Oncology Fellows Day Fall 2024 workshop are pictured in the FDA Building 2 atrium. The fellows spent the day with FDA Oncology clinical reviewers and OCE Director Richard Pazdur learning about FDA's role in oncology drug development.
 FDA Oncology staff gathered in October to celebrate Oncology Center Director Richard Pazdur's 25th year at the FDA. He is pictured in the front row at left holding his cardboard cutout, a gift from the staff. FDA Commissioner Robert Califf is in the front row, center, wearing a blue sweatshirt for FDA's Tailgate Day picnic for staff.
Dr. Kevin Breen has recently joined OCE in the Division of Oncology 2 (DO2) as a medical officer.
What is your educational and professional background?
I received my MD/PhD in Neuroscience from the University of Utah, completed Internal Medicine Residency at the University of Arizona, and most recently my Medical Oncology Fellowship with NCI. Prior to this I completed three BS degrees in Microbiology, Molecular Biology, and Philosophy at the University of Idaho. My academic route has allowed me to do clinical and basic science research aiming to understand how the immune system eliminates hypermutant cancers with and without checkpoint inhibitors. This work has thus far been done in Glioblastoma patients with a special interest in those who have lost Lynch syndrome genes and by knocking out Lynch syndrome genes in a mouse model of Glioblastoma changing it from a low tumor mutational burden to a high one.
Why did you join FDA Oncology?
I joined the FDA because it is at the forefront in evaluating ever more molecularly targeted therapies with great impact on patients but also because it has a robust research culture with many fascinating projects. I hope to bring my interest and expertise in Lynch syndrome genes and hypermutation to understand how a high tumor mutational burden can best be used as a biomarker in clinical studies.
What do you like to do in your free time?
In my free time I’m an avid runner and play acoustic guitar. Even though my marathon days are behind me, my friends and I are trying to run half marathons in all the surrounding states.
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.
OCE PULSE Q & A
Question: Does the FDA collaborate with the American Society of Hematology (ASH)?
Answer: Yes, FDA Oncology co-hosts an annual FDA-ASH Collaboration: A Workshop on Regulatory Science in Hematology. The participants range from hematology fellows to mid-career faculty. The workshops include didactic lectures, panel discussions, and case discussions based on recent drug approvals to cover a variety of regulatory science and policy educational topics. This workshop is held once a year in the fall. ASH plans to provide information on the fall 2025 this coming summer.
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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 20: zanidatamab-hrii for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
November 8: obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
November 15: revumenib for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (HMT2A) translocation in adult and pediatric patients 1 year and older.
November 19: updated drug labeling for fludarabine phosphate under Project Renewal, an OCE initiative aimed at updating labeling for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date.
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
FDA Approval Summary: Olutasidenib for Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia with an Isocitrate Dehydrogenase-1 Mutation. Clinical Cancer Research
Administrative Aspects of Molecular Diagnostics-Oversight, Regulatory Approval Process, Clinical and Operational Workflows, and Payment Models. JCO Oncology Practice
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.
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