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Recent and Upcoming Public FDA Oncology Events
 OCE's Project Asha is a new initiative in collaboration with the White House Cancer Moonshot Program to increase oncology clinical trial access India.
Above, OCE leadership, OCE's Project Orbis leadership, and FDA India Office staff members recently met at the FDA White Oak campus in Silver Spring, MD, to discuss this project. For further details, please see Project Asha.
Dr. Sonia Singh is a pediatric hematologist/oncologist in the Division of Oncology 2 and joined FDA Oncology in 2018.
What is your educational and professional background?
I received my medical degree from Drexel University College of Medicine in Philadelphia, PA. In my final year of medical school, I had a very memorable rotation at St. Christopher’s Hospital for Children for a pediatric hematology/oncology elective. It was eye-opening to witness the resilience of children with cancer, the impact oncologists can make during such a crucial time in the lives of their pediatric patients and the great pleasure of following survivors longitudinally.
Following this, I pursued a pediatric residency at New York-Presbyterian Hospital/Weill Cornell Medical Center. My clinical experiences while rotating in the pediatric unit at Memorial Sloan Kettering Cancer Center confirmed my desire to pursue additional oncology training. I subsequently completed a pediatric hematology/oncology fellowship through a joint program at these same cancer centers.
During my fellowship, I was fortunate to have a great deal of exposure to patients receiving investigational therapies through clinical trials. I was also involved in reviewing study protocols through the institution’s Pediatric Steering Committee, which further piqued my interest in drug development. I also did research on Fanconi anemia at the Laboratory of Genome Maintenance at Rockefeller University.
What motivated you to join FDA Oncology?
Due to the rarity of pediatric cancers, the limited treatment options available for many tumor types, and the significant toxicity profiles of treatments such as traditional chemotherapy, which can include long-term harmful effects on growth and development, I highly appreciated the importance of clinical trials to identify safe and effective therapies that are much needed by this patient population. By the end of my fellowship, I knew I wanted to make a career in evaluating and helping advance treatment options for pediatric patients with cancer and patients with rare tumors, which is now the focus of my work.
The factors that were key to my decision to pursue the clinical reviewer role were:
- the ability to have a broad and positive impact on drug development and consequently patients.
- the dynamic nature of the work.
- the opportunity to advocate on behalf of pediatric patients and improve their access to clinical trials and new therapies.
- the range of academic opportunities available to reviewers.
Additional features that made this career path even more appealing were the opportunity to collaborate with experts from other disciplines, both within the FDA and externally (academic/industry/advocacy leaders), and a favorable work-life balance.
What do you like to do in your free time?
I love to spend my free time outdoors—whether hiking with my dog, taking my son to the park, gardening, apple picking in the fall or enjoying walks at the beach in the summertime. I am also a big fan of travel and exploring different cultures and cuisines!
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 is approving pediatric indications based on adult data, considering children as “little adults.”
Truth: When the course of the disease and effects of the drug are sufficiently similar in adult and pediatric patients, the FDA can use data obtained in adults to support approval of a drug in pediatric patients. However, in these cases, approvals are based on the totality of the available information, including data obtained in pediatric patients and pharmacokinetic and pharmacodynamic studies. The FDA does not consider pediatric patients to be “little adults” and takes into consideration their age and stage of development in addition to their size.
Have a regulatory question? Send us your questions at projectsocrates@fda.hhs.gov, with the subject line “OCE Pulse Question.”
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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!
April 23, 202: Tovorafenib for patients 6 months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
April 23, 2024: Lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors.
April 22, 2024: Nogapendekin alfa inbakicept-pmln for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
April 18, 2024: Alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase positive non-small cell lung cancer, as detected by an FDA-approved test.
April 10, 2024: Selpercatinib for four indications including non-small cell lung chancer, medullary thyroid cancer, and locally advanced or metastatic solid tumors for which there are no satisfactory treatment options.
April 5, 2024: Fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior treatment and have no satisfactory alternative treatment options.
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: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation. Clin Cancer Res.
Pharmacokinetic models for first-in-human dose selection of immune-activating products in oncology. Regul Toxicol Pharmacol.
Remote Monitoring and Data Collection for Decentralized Clinical Trials. JAMA Netw Open
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.
Project Livin’ Label: Listen to the “behind the scenes” discussions of the development and backstory of approved oncology drugs. All are free with CME credit offered by AACR.
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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