Happy New Year from FDA Oncology!

U.S. Food and Drug Administration sent this bulletin at 01/02/2024 07:50 AM EST

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OCE PULSE

January 2024

Happy New Year from FDA Oncology!

Consider this monthly newsletter as your source for news from FDA Oncology, including cancer drug approvals, public events and training opportunities. More than 100 FDA oncologists and cancer scientists work as a team and you can learn more about them in the featured spotlight.

We want to hear your feedback! Reach out to @FDAOncology on X (formerly Twitter) or email us at projectsocrates@fda.hhs.gov.

Recent and Upcoming Public FDA Oncology Events

Are you attending GI ASCO in San Francisco? Join FDA Oncology for lunch at the Meet the Expert Luncheon on January 19, 2024, from 12:45 PM – 1:45 PM – learn more about who we, what we do & unique career opportunities at the FDA!

January 10, 2024: Conversations on Cancer: Cancer Drug Development Year in Review. 2:00 pm - 3:30 pm ET. Register Here.

February 22, 2024: FDA-IMS Joint Workshop: Defining Patient Populations for Clinical Trials in Multiple Myeloma. Register Here.

ICYMI – Catch the recent interview on YouTube with author and journalist Nathan Vardi on what it takes to bring a new cancer treatment – Conversations on Cancer: How Biotech Built a Blockbuster Cancer Drug.

Watch the recent Oncology Drugs Advisory Committee Meetings (ODAC) discussions on timely completion of confirmatory trials after accelerated approval – with a focus on pralatrexate and belinostat.

For a full list of our past and upcoming events, check out OCE Meetings and Workshops.

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.

Hot off the press the latest episode of Project Livin’ Label – fam-Trastuzumab Deruxtecan-nxki: The Backstory – is now available! Watch the episode here and read the labeling to receive free CME credit, offered by AACR!

Oncology Regulatory Science Online Lecture Series: Learn about INDs, Expedited Pathways, Clinical Trial Design, Statistics, Patient-Focused Drug Development, Real-World Evidence, and more!

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.

Get to Know Us - Why I joined FDA Oncology

Hi, my name is Ladi Akinboro and I have been at FDA Oncology for about 3 years.

What is your educational and professional background? I received my degree from the University of Ilorin in Nigeria in 2006. Afterwards, I completed a rotating medical internship and practiced general medicine in Nigeria for almost four years. Then I took a short detour to obtain an MPH degree, with a focus in biostatistics/clinical research, before I undertook my residency, and chief residency, in internal medicine at Montefiore New Rochelle Hospital in New York. I completed my fellowship training in hematology and medical oncology at Boston University School of Medicine/Boston Medical Center where I also served as a chief fellow.

I joined FDA as a clinical reviewer on the thoracic/head and neck cancer team in the Division of Oncology 2 in July 2020 and completed a detail as a clinical team lead. I am currently on detail as an Associate Director of Safety in the Office of Oncologic Diseases. I am also a physician in the medical corps of the U.S. Army Reserve.

What motivated you to join FDA Oncology? I decided to join the FDA because of the scope and impact of FDA’s role in the regulation of drug development on the health of millions of Americans, and potentially many more people far beyond the shores of this country. Since joining FDA, I’ve been so impressed by how we align, daily, scientific principles and clinical expertise with the regulatory framework within which we operate with the best interests of patients at the heart of it all. I also love the intellectual stimulation of our work, and I admire how seriously everyone here takes the immense responsibility of helping safeguard the nation’s health and how we work collaboratively in multidisciplinary teams to that end. I’m extremely proud of what we all do at the FDA and the part I get to play in it.

What do you like to do for fun? I love running, playing and watching soccer, and hiking/camping with friends. I am also a fan of anything history, so I love reading history books, visiting history museums, and I do a just a little bit of travel to visit some historical sites.

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.

True or False?

The FDA does not consider the patient perspective during the drug approval process.

ANSWER: False! The FDA deeply values the experience of patients, and has formal ways of evaluating this during the review process through initiatives including the OCE Patient-Focused Drug Development program.

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 1: Pirtobrutinib for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma(CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

November 27: Nirogacestat for adult patients with progressing desmoid tumors who require systemic treatment. This is the first approved treatment for desmoid tumors.

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

Use of patient-reported outcomes (PRO) data to complement exposure-response analysis in early clinical cancer drug development.

FDA Approval Summary: Ivosidenib in Combination with Azacitidine for Treatment of Patients with Newly Diagnosed Acute Myeloid Leukemia with an IDH1 Mutation.

Interested in learning more about OCE?

Read our FDA Oncology Center of Excellence (OCE) Annual Report
follow us on Twitter @FDAOncology, or send us an email at FDAOncology@fda.hhs.gov.

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