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FDA Oncology Upcoming Events
 Dr. Maria Garcia-Jimenez recently joined FDA Oncology in the Division of Oncology 1.
What is your educational and professional background?
I am a medical oncologist, health services researcher, and cancer health equity champion. I did my training at institutions around the country, from UCSF and UC Berkeley to NYU and UCLA. Prior to joining the FDA, I was faculty at UCLA, where I completed my hematology/oncology fellowship, and I served as the Director of Oncology Research at Olive View-UCLA (one of the safety net hospitals in Los Angeles County). As a health services researcher I conducted grant funded researcher implementing and evaluating patient level interventions to improve participation in clinical trials by Latin/Hispanic and primary Spanish speaking patients.
Why did you join FDA Oncology?
I joined FDA Oncology because I very much identified with its public health and service-oriented mission, and it seemed to be a great place to be challenged, develop new skills, and find a new avenue to continue advocating for equity in cancer care and cancer research.
What do you like to do in your free time?
In my free time I enjoy traveling, listening to audiobooks, baking treats, exploring new cities, and spending time with my 11-month-old son and my husband.
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.
Q: Does the FDA consider other expert opinions during the drug approval process?
A: Yes, the Oncologic Drugs Advisory Committee (ODAC) is a committee of experts from outside the agency that reviews and evaluates data on the safety and effectiveness of marketed and investigational cancer drugs. When needed, the FDA can convene an ODAC meeting to get advice from the experts and encourages patients and other interested people to share their views as well.
For more information, see Oncologic Drugs Advisory Committee. committees/oncologic-drugs-advisory-committee
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.
August 1: dostarlimab in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent endometrial cancer.
August 2: accelerated approval to afamitresgene autoleucel for adults with unresectable or metastatic synovial sarcoma.
August 6: vorasidenib for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.
August 14: axatilimab-csfr for treatment of chronic graft-versus-host disease (cGVHD) in adult and pediatric patients weighing at least 40 kg.
August 15: durvalumab with platinum-containing chemotherapy as neoadjuvant treatment followed by single-agent durvalumab as adjuvant treatment for adults with respectable non-small cell lung cancer (NSCLC).
August 19: lazertinib in combination with amivantamab-vmjw for patients with locally advanced or metastatic NSCLC.
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 issued the final guidance: Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases. This version of the guidance replaces the draft guidance published in January 2023.
US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations. Journal of Clinical Oncology.
Improving Collection and Analysis of Overall Survival Data. Clinical Cancer Research.
Treatment of Acute Myeloid Leukemia in the Community Setting. The Oncologist.
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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