|
Upcoming FDA Oncology Events
On June 26, FDA issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies.
Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. Read an FDA news release about the new guidance.
 Project 5 in 5 is a crowdsourcing initiative to ultimately identify 5 clinically relevant questions that can be answered through use of pragmatic clinical trials, using FDA-approved oncology therapies, over the next 5 years. The resulting ideas will be shared with government agencies, cooperative groups, and others who may be interested in implementing these pragmatic clinical trials. Listen to Dr. Richard Pazdur give the background to this project.
The crowdsourcing initiative began May 5 and will close July 5. The OCE invites anyone interested to Visit the Project 5 in 5 Crowdsourcing page and submit your ideas!
Dr. Crystal Lu is a clinical analyst with the Division of Hematologic Malignancies 1.
What is your educational and professional background?
I’m a California native and majored in Biochemistry/Chemistry at University of California San Diego. I received by PharmD from The Ohio State University. I completed my PGY1 pharmacy residency at NorthShore University Health System and my PGY2 oncology residency at Henry Ford Hospital.
I became interested in oncology after shadowing a multiple myeloma pharmacist in clinic during a pharmacy school rotation. I was drawn to the professional collaboration in solving complex drug issues including drug interactions, dose modifications, patient adherence, toxicity management, financial challenges and much more.
After my training, I worked at the University of Maryland Medical Center for two years as an inpatient oncology pharmacist rounding on the leukemia team. In 2019, I transitioned to the National Institutes of Health to join the lymphoma and HIV-associated malignancies teams to treat patients on clinical trials. It was humbling and rewarding to be part of research teams that focused on improving treatment options for rare malignancies.
What motivated you to join FDA Oncology?
With my interest in clinical trials, the opportunity to work at the FDA aligns with my goal to have a positive impact on available treatments for cancer patients. As I’m still very new to the FDA, I’m excited to learn more about the drug development and application review process.
What did you hope to gain by joining FDA?
To gain a deeper understanding of clinical trial design and apply what I learn to drug applications. I’m also looking forward to participating in FDA OCE programs and projects.
What do you like to do in your free time?
I love trying new restaurants, relaxing at coffee shops, exploring new cities, taking workout classes and sending time with my family (husband and fur-child named Mocha).
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.
Myth and Truth
Myth: The FDA does not engage or collaborate with other global oncology regulatory authorities.
Truth: Although the FDA reviews and approves oncology drugs independently, FDA regularly engages with other global oncology regulatory authorities. Read more about OCE's Project Orbis.
In addition to Project Orbis, the FDA Oncology Center also interacts with other regulatory authorities via other forums, including monthly calls, or “clusters” with multiple agencies to discuss specific applications, bilateral calls with individual authorities, public workshops and professional society annual meetings, to name a few.
|
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!
June 6, 2024: Imetelstat for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
June 12, 2024: Selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory. Accelerated approval.
June 13, 2024: Repotrectinib for adult and pediatric patients 12 years and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.
June 14, 2024: Durvalumab with carboplatin plus paclitaxel followed by single-agent durvalumab for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).
June 17, 2024: Pembrolizumab with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.
June 21, 2024: Adagrasib plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Recent FDA Withdrawal
May 16, 2024 – FDA announced the final withdrawal of the approval of infigratinib for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGF2 fusion or other rearrangement.
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
2024 ASCO Annual Meeting FDA Abstracts:
- Adoption of Decentralized Trial Elements in Cancer Clinical Trials Supporting FDA Approvals During COVID-19.
- Enrollment of older adults in clinical trials for oncology indications, 2010-2020: An evaluation by the FDA.
- FDA Analysis of representation of Indian Americans and Indians in cancer clinical trials leading to approval from 2010 to 2022.
- FDA analysis of immune checkpoint inhibitors in combination with vascular endothelial growth factor tyrosine kinase inhibitors in the second-line treatment of patients with advanced non-small cell lung cancer.
- Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials.
- Project Facilitate: An analysis of the increased utilization in the oncology single patient expanded access pathway.
- Under-representation of Asian Americans, and Native Hawaiians, and other Pacific Islanders in cancer therapeutic clinical trials that led to the FDA approvals in 2010-2022.
Reflections and Roadmaps: Career Development Beyond the FDA-AACR Oncology Educational Fellowship. Clinical Cancer Research.
Moving Immunotherapy into the Treatment of Resectable Non–Small Cell Lung Cancer. American Society of Clinical Oncology Educational Book.
|
