|
Upcoming FDA Oncology Events
Dr. Andrew Bernstein recently joined FDA Oncology in the Division of Oncology 2.
What is your educational and professional background?
I grew up in Washington, DC, before obtaining my bachelor’s degree at Carleton College in Northfield, Minnesota. I then spent a year doing research at Massachusetts General Hospital in the GI surgical oncology department before returning to DC for medical school at George Washington University School of Medicine and Health Sciences. After medical school, I completed two years of internal medicine residency at Thomas Jefferson University Hospital in Philadelphia, with the goal of pursuing a career in thoracic oncology, with a particular interest in NSCLC in the HIV+ population. Unfortunately, I became severely immunocompromised during residency and was unable to continue working in the hospital setting.
Why did you join FDA Oncology?
The opportunity to work at FDA on the cutting-edge frontier of oncologic drug development and regulatory science has been a fantastic fit for me. I have loved learning from brilliant minds in DO2, and from the many multidisciplinary teams we work with in our drug reviews.
What do you like to do in your free time?
In my free time, I love playing tennis, indoor cycling, board game nights, and the DC food scene.
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 real-world data useful for clinical decision making in oncology?
ANSWER: Yes! Real-world data (e.g., EHR, claims, registry data) can be incorporated into retrospectively or prospectively designed high quality non-interventional studies or complement prospective clinical trial data, providing valuable insights into the effectiveness and safety of treatments in more diverse, generalizable patient populations.
For more information, visit OCE’s Real-World Evidence Program.
Have a regulatory question? Send us your questions at projectsocrates@fda.hhs.gov, with the subject line “OCE Pulse Question.”
|
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!
September 25: osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. This application was granted priority review and breakthrough designation.
September 20: isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for adults with multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).
September 19: amivantamab-vmjw with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
September 17: pembrolizumab with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.
September 17: ribociclib for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication.
September 12: atezolizumab and hyaluronidase-tqjs for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS).
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: Belzutifan for Patients with Advanced Renal Cell Carcinoma. Clinical Cancer Research
Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies. Journal of Clinical Oncology
Post-approval evidence generation: a shared responsibility for healthcare. Nature Medicine
False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring ATM and CHEK2 Mutations. JCO Precision Oncology
Draft Guidance: Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs
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.
|
|
