Fred Hutch statement regarding the FDA approval of CD19 immunotherapy, lisocabtagene maraleucel

The newly-approved CAR T-cell therapy was developed in part by Fred Hutch physician-scientists

SEATTLE — Feb. 5, 2021 — Today the U.S. Food and Drug Administration approved the chimeric antigen receptor immunotherapy, Breyanzi (lisocabtagene maraleucel or liso-cel), for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

The approval was granted to Bristol Myers Squibb, and development of the therapy was supported by physician-scientists at Fred Hutchinson Cancer Research Center.

Aspects of liso-cel’s chimeric antigen receptor (CAR) technology were developed at Fred Hutch and were then licensed in 2013 to Juno Therapeutics, which was later acquired by Celgene and then Bristol Myers Squibb. Other Fred Hutch physician-scientists participated in the multi-site clinical trial to investigate liso-cel’s safety and efficacy.

Dr. David Maloney, who holds the Leonard and Norma Klorfine Endowed Chair for Clinical Research, is the medical director of cellular immunotherapy at Fred Hutch and medical director of the Bezos Family Immunotherapy Clinic at Seattle Cancer Care Alliance, Fred Hutch’s clinical care partner. He offered the following statement:

“The FDA approval of liso-cel marks a giant step forward in CAR T-cell therapy and for effective treatments for NHL. Clinical trials have shown the treatment to be safe and effective, and with the FDA approval, we will be able to make the treatment available to more patients. While this treatment needs to be administered by trained clinicians, the approval opens up the possibility for patients to receive the treatment before their disease is wide-spread and this will lead to better outcomes for more patients.”

Maloney also said: “Given that we’re seeing a better safety profile and fewer toxic side-effects with liso-cel, we’ve also been able to deliver it to most of our patients in an outpatient setting.” 

T-cell immunotherapy involves collecting a patient’s own immune cells and modifying them to target and destroy cancer cells while leaving healthy cells alone. Liso-cel engineers T cells to seek a protein called CD19, on cancer cells. 

Fred Hutch has long been known for its expertise in using the immune system to fight cancers, starting in the 1970s with the Hutch’s groundbreaking work in bone marrow transplantation. Those efforts led to a Nobel Prize in 1990.

The center’s discoveries in bone marrow transplantation sparked other advancements in immune-based therapies, including CAR T-cell therapy and T cell receptor therapies, as well as cell and gene therapies for infectious diseases such as HIV. Scientists at Fred Hutch continue to test experimental T-cell therapies for breast cancer, leukemia, lymphoma, lung cancer, Merkel cell carcinoma, mesothelioma and multiple myelomas. 

Note: Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

Cell therapy milestones at Fred Hutch:

Fred Hutch announcement of Juno Therapeutics in 2013, a biotech spinout to advance cell therapies:

Research paper on the CAR T design supporting liso-cel, published in 2015 in Cancer Immunology Research:

Bezos Family Immunotherapy Clinic opens in 2016, to support CAR T and other cell therapy clinical trials:

Research paper on phase 1 results of the clinical trial leading to liso-cel, published in 2016 in Science Translational Medicine.

Research study giving a detailed look at CAR T-cell therapy side effects, to make the emerging therapy safer. Study presented at the 2017 annual meeting of the American Society of Hematology:

Early proof of how immune cells can cure cancer: