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Upcoming FDA Oncology Events
Dr. Lun Li has recently joined OCE in the Division of Oncology 1 (DO1).
What is your educational and professional background?
I recently earned my PhD in Statistics from The Ohio State University, building on a BS and MS from the University of Washington. My academic research focused on dimensionality reduction and compositional data analysis. Before joining the FDA, I worked on a range of projects in areas such as finance, insurance, law enforcement analytics, and medical data analysis. While these experiences allowed me to apply advanced statistical techniques in diverse fields, transitioning to the FDA presents an exciting opportunity to specialize in clinical trials and healthcare data. I am eager to deepen my expertise in this new field and contribute to the development of cancer therapies that improve patient outcomes.
Why did you join FDA Oncology?
I am passionate about contributing to work that makes a meaningful difference in society and improves people's well-being, and FDA Oncology provides the opportunity to engage in impactful work that directly benefits patients and supports broader efforts to advance healthcare. I also look forward to collaborating with experts in oncology and expanding my knowledge in clinical trial methodologies.
What do you like to do in your free time?
In my free time, I enjoy reading a wide variety of books, exploring and cooking dishes from various cultural traditions, playing tons of video games, and spending time with my pet bunny, Bun.
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: Is FDA Oncology involved in oncology prescription drug labeling?
Answer: Yes! Prescription drug labeling (e.g., U.S. Prescribing Information [USPI] ) contains a summary of the essential scientific information needed for the safe and effective use of the drug. The USPI provides healthcare providers who use oncology prescription drugs unbiased information regarding the use of the drug, including the setting in which the drug has been shown to be safe and effective, recommended dose and schedule, recommended modifications for toxicity, in patients with renal or hepatic impairment, or based on drug interactions, as well as a summary of potential side effects including severity and frequency. A multidisciplinary FDA team typically includes physicians, pharmacologists, toxicologists, statisticians, pharmacists, chemists/biologists, safety specialists, and regulatory scientists, and together they review the information in the USPI.
For more information, visit About Oncology Prescription Drug Labeling.
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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 3: nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
October 10: inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
October 18: zolbetuximab-clzb, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.
October 29: asciminib for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
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
The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals. Pharmacoepidemiology and Drug Safety
An Overview of Myeloid Blast-Phase Chronic Myeloid Leukemia. Cancers
The Retrofit: Lessons From Sotorasib's Dosing Conundrum. Journal of Clinical Oncology
FDA Approval Summary: Capecitabine Labeling Update under Project Renewal. Clinical Cancer Research
Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug. Journal of Clinical Oncology
Most common symptomatic adverse reactions of cancer treatments from US drug labels (2015-2021) to inform selection of patient-reported outcomes. Value Health
FDA Approval Summary: Teclistamab - A Bispecific CD3 T-cell Engager for Patients with Relapsed or Refractory Multiple Myeloma. Clinical Cancer Research
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation. Clinical Cancer Research
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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