In this interview, Dr. Jason Mouabbi, OncData Editorial Board Member and Breast Medical Oncologist at MD Anderson Cancer Center, speaks with Dr. Ross Maclean and Michael Glover about the debate surrounding accelerated FDA approvals, including their benefits, risks, and ways that physicians, patients, pharmaceutical companies, and the FDA can collaborate to maximize the impact of accelerated approval drugs.

Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward

The mission of Oncology Data Advisor is to provide the multidisciplinary team with expert insights into clinical best practices and research progress in cancer care.

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Dr. Rahul Banerjee, Assistant Professor in the Division of Medical Oncology at the University of Washington, Fred Hutchinson Cancer Center, is currently serving as chair of i3 Health’s online activity and fellows meeting series, Leveraging BCMA-Directed Therapies for Improved Patient Outcomes in Relapsed/Refractory Multiple Myeloma. Since recording the activity, numerous updates have occurred in research for this field, with the most notable being the recent expanded approvals of idecabtagene vicleucel and ciltacabtagene autoleucel for earlier lines of therapy. In this interview, Dr. Banerjee shares additional insight into these expanded approvals and how they affect the treatment landscape for patients with multiple myeloma. 

Click the links below for the full activity! 

Online Accredited CME/NCPD Activity: https://www.i3health.com/course-information/leveraging-bcma-directed-therapies-for-improved-patient-outcomes-in-relapsedrefractory-multiple-myeloma

Live or Virtual Meeting Series: https://www.i3health.com/live/hemonc-fellows-lecture-series-leveraging-bcma-directed-therapies-for-improved-patient-outcomes-in-relapsedrefractory-multiple-myeloma

Additional Advances in Multiple Myeloma Research and Clinical Trials With Rahul Banerjee, MD, FACP

In this video, Dr. Assuntina G. Sacco, Associate Professor of Internal Medicine, Co-Director of the Hanna and Mark Gleiberman Head and Neck Cancer Center, and Disease Team Leader–Head and Neck at UC San Diego Moores Cancer Center, answers questions asked by the audience during her CME/NCPD–approved activity with i3 Health, Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: New Insights and Real-World Evidence for Improved Patient Outcomes. Dr. Sacco shares insights into targeted mutations to test for, recommendations for patient education, the future of HPV therapeutic vaccines, monitoring for immune-related adverse events, and more!

Claim free CME/NCPD credit for Dr. Sacco's activity here: https://www.i3health.com/course-information/recurrent-and-metastatic-hnscc-new-insights-and-real-world-evidence-for-improved-patient-outcomes

Recurrent/Metastatic HNSCC: Answers To Frequently Asked Questions With Assuntina G. Sacco, MD

In this video, Dr. Neal Weinreb, Voluntary Associate Professor for Human Genetics at the University of Miami Miller School of Medicine, answers questions asked by the audience during his CME/NCPD–approved activity with i3 Health, Exploring Treatment Advances for Acid Sphingomyelinase Deficiency (ASMD) in Adults. Dr. Weinreb shares insights into screening for lysosomal storage disorders, genetic carrier testing, resources for family and caregivers, the future of treatment with olipudase alfa, and more. 

Click the links below for the full activity! 

Online Accredited CME/NCPD Activity: https://www.i3health.com/course-information/exploring-new-treatment-advances-for-acid-sphingomyelinase-deficiency-in-adults

Live or Virtual Meeting Series: https://www.i3health.com/live/exploring-new-treatment-advances-for-acid-sphingomyelinase-deficiency-in-adults-1

Acid Sphingomyelinase Deficiency: Answers To Frequently Asked Questions With Neal Weinreb, MD

In this installment of Oncology Data Advisor's Exploring Artificial Intelligence in Oncology series, Dr. Waqas Haque, Fellows Forum member and incoming Hematology/Oncology Fellow at the University of Chicago, speaks with Tracey Sikora, Co-Founder of Every Cure, a nonprofit organization whose mission is to repurpose existing FDA-approved drugs for other indications, especially in rare diseases. 

Check out the discussion to learn more about: 
•	Challenges in finding treatments for rare diseases, including sparse data, low patient numbers, and lack of financial incentive for pharmaceutical companies
•	Every Cure’s mission to unlock the potential of drugs that are already on the market
•	Harnessing the latest AI and machine learning technology to structure data in a biomedical knowledge graph, looking at drugs, diseases, pathways, and targets
•	Barriers in drug repurposing, including clinical validation and eventual approval
•	The Advanced Research Projects Agency for Health (ARPA-H) grant and the importance of federal funding for rare disease research
•	How to develop efficient clinical trials without a large sample size
•	The future of AI-enabled drug discovery in oncology 
•	And more!

Every Cure: Unlocking Drug Potential With Artificial Intelligence - Waqas Haque and Tracey Sikora

In honor of Acute Myeloid Leukemia (AML) Awareness Day, Oncology Data Advisor Editorial Board and Fellows Forum members Tristan Knight, MD, FRCPC, Richa Thakur, MD, and Joseph Kalis, PharmD, BCOP, hosted a live panel discussion covering the evolving treatment landscape for AML, including: 
•	Novel therapies and combinations such as chimeric antigen receptor (CAR) T-cell therapy and isocitrate dehydrogenase (IDH) inhibitors
•	The role of measurable residual disease (MRD) testing
•	Considerations for pediatric transplant and cellular therapy
•	Words of hope for patients undergoing treatment for AML

Additionally, they answered live questions from the audience, including: 
•	Do you have any first-line treatment recommendations for patients with a KMT2A mutation? 
•	When do recommend that patients participate in a clinical trial? 

Take a listen to hear the panelists’ answers to these questions and their perspectives on the ever-changing therapeutic landscape for AML!

Accelerated Approvals in Oncology: Benefits, Risks, and the Way Forward

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