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FDA’s ODAC Endorses New Indications for 2 CAR-T Therapies for Myeloma

Rye Brook, N.Y., March 15, 2024 – Today’s vote by the FDA’s Oncologic Drugs Advisory Committe (ODAC), a group of independent cancer experts, stating that the benefits of two CAR T-cell therapies in earlier lines of multiple myeloma outweigh the risks reinforces the value of immune-based approaches for treating blood cancer and the importance of giving patients and their oncologists additional options at all stages of treatment.   

“One of the most common questions we get from patients about CAR T is why they aren’t eligible for it sooner,” says Gwen Nichols, M.D., Chief Medical Officer of The Leukemia & Lymphoma Society. “Blood cancer is complex and patient care is highly individualized. The more safe and effective options available to oncologists and patients at all stages of their cancer, the better.” 

Since its introduction in 2017, CAR-T has mainly been available to patients with advanced blood cancer, who have limited or even sometimes no other treatment options. If the FDA follows the advice of the panel, patients with multiple myeloma could be eligible for CAR T-cell therapy as early as after a first disease recurrence.  

CAR T-cell therapy works by engaging a patient’s own immune system to treat their cancer. This landmark approach to cancer treatment was developed over decades of research.  

The Leukemia & Lymphoma Society provided funding for CAR T-therapy beginning in the 1990s, from the earliest stages of research that helped identify specific genetic targets for the immune system all the way to a clinical trial that was the basis for FDA approval of one of the first two CAR T-cell treatments approved in 2017. 

“CAR-T has saved and extended countless lives of people with multiple myeloma, lymphoma and certain forms of leukemia,” says LLS’s Chief Scientific Officer, Lee Greenberger, Ph.D. “But CAR-T also has limitations which is why LLS is heavily invested in improving CAR T-cell therapy and finding next generation approaches that give the immune system the tools it needs to attack a patient’s cancer safely.”

About The Leukemia & Lymphoma Society

The Leukemia & Lymphoma Society® (LLS) is the global leader in the fight against blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin's disease, and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.  
Founded in 1949 and headquartered in Rye Brook, NY, LLS has regions throughout the United States and Canada. To learn more, visit Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET. For additional information, visit Follow us on Facebook, X, and Instagram.

Media Contact:
Ryan McDonald