|
Upcoming FDA Oncology Events
My name is Kamar (Kami) Godder and I joined the Division of Hematologic Malignancies 1 as a clinical reviewer in 2021.
What is your educational and professional background?
I received my MD from Hebrew University Medical School in Jerusalem and completed pediatric residency in Hadassah Medical Center. Because there were no subspecialty training programs in Israel at the time, I came to the US to train in pediatric hematology-oncology. I was accepted at Memorial Sloan Kettering Cancer Center in New York, where I also served as a chief fellow. My first clinical appointment was as a general hematologist/oncologist at North Shore Hospital/Cornel Medical College, but soon enough I revealed my passion for bone marrow transplantation and was exploring transplant options. I joined the University of South Carolina, Columbia, under the leadership of Dr. Jean Henslee-Downy, where we were among the first groups to successfully perform mismatched related (Haplo) transplants. I also received my MPH in this university. Then I was recruited to lead the Pediatric Bone Marrow Transplant Unit at Oregon Health and Science University in Portland. Being far from home and family, I decided to move back East, and accepted an offer to chair the Pediatric Hematology/Oncology Division at Virginia Commonwealth University where I built the sickle cell, late effects and, neuro-oncology units and led the bone marrow transplant unit. In 2013, I was recruited by Nicklaus Children’s Hospital in Miami to lead and develop the largest pediatric hematopoietic stem cell transplant unit in the city.
Why did you join FDA Oncology?
All through my career I was involved in clinical research, from investigator-initiated trials to industry and Children’s Oncology Group trials, and I served on multiple IRBs and DSMBs. When the time came to step back from clinical practice, it was only natural that I would still be involved in clinical trials. The FDA provides a unique opportunity of combination of clinical trials along with its regulatory aspects—both fields close to me. In addition, after many years of caring for patients, I wanted to expand my focus from caring for the individual to caring for the group, as this was the reason I studied for the MPH years earlier. FDA gives me a fantastic opportunity to combine it all, along with academic interests.
What do you like to do in your free time?
Spend time with my family, travel, bake, read, explore art and design, and volunteer.
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: Why are pharmacists so important in oncology specifically?
Answer: Pharmacists play an important role in oncology because cancer treatments, including drugs and biologic therapies, often have complex toxicities, drug-drug interactions, and narrow therapeutic windows. Their expertise allows them to manage these risks and optimize patient outcomes. Oncology pharmacists are specially trained to understand the unique properties of cancer medications, including how to minimize side effects, adjust dosages, and monitor patient responses. This specialized knowledge ensures that treatment regimens are safe and effective, making them an essential part of the oncology care team.
|
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!
December 4: durvalumab for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
December 4: zenocutuzumab-zbco for adults with the following:
- advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
- advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
December 13: cosibelimab-ipdl for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.
December 20: encorafenib with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF v600E mutation, as detected by an FDA-approved test.
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
Autopsy of a Drug Withdrawal - The Case of Melphalan Flufenamide. New England Journal of Medicine.
Project Facilitate: 5 Years of Progress, Outreach, and Service. The ASCO Post.
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.
|
|
