FDA Approves Second CAR T Therapy for Diffuse Large B-Cell Lymphoma

May 02, 2018

TAMPA, Fla. – There is a new Chimeric Antigen Receptor Therapy (CAR T) option for patients with diffuse large B-cell lymphoma (DLBCL). The Food and Drug Administration (FDA) yesterday approved the expanded use of Novartis’s KymriahTM. Previously, the therapy was available for children and young adults up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL). Now, Kymriah is available for adults 18 years of age and older with DLBCL who have relapsed after previous therapies.

“CAR T therapy has revolutionized the way we treat patients with B-cell malignancies. It has given patients who have relapsed on previous therapies hope that they can overcome their disease. With this approval, we now have two therapy options for diffuse large B-cell lymphoma patients – Kymriah or Gilead’s Yescarta™. Moffitt is the only certified treatment center in the state of Florida that can offer both therapies to its patients,” said Frederick Locke, M.D., Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy.

“Kymriah has proved to be a great advance in acute lymphoblastic leukemia. Patients can go into complete remission with one infusion of this gene therapy,” said Bijal Shah, M.D., assistant member of the Department of Malignant Hematology. “We are excited to be able to bring Kymriah to even more of our patients who are not seeing improvement with current therapies.”

CAR T is a personalized gene therapy using a patient's own immune cells, or T cells, to fight cancer. For this treatment, a patient's T cells are removed and engineered with additional receptors to help identify, attack and ultimately destroy the cancer cells.  The re-engineered T cells are then infused back into the patient's body in a single treatment, enabling the body's immune system to better combat the disease.

“Moffitt is a leader in CAR T therapy. We have treated more than 80 patients with this therapy in the clinical trial and commercial setting,” said Locke. “We have also increased our staff and expanded our clinical space to accommodate our CAR T patients.”

Moffitt is involved in multiple clinical trials investigating the use of CAR T therapy for other cancers including multiple myeloma.

Novartis Release: https://novartis.gcs-web.com/Kymriah-tisagenlecleucel-first-in-class-CAR-T-therapy-from-Novartis-receives-second-FDA-approval-to-treat-appropriate-r-r-patients-with-large-B-cell-lymphoma

Media Availability: Drs. Locke and Shah are available to discuss CAR T therapy. To schedule an interview, please contact Kim Polacek at 813-745-7408 or Kim.Polacek@Moffitt.org.

Novartis Release: https://novartis.gcs-web.com/Kymriah-tisagenlecleucel-first-in-class-CAR-T-therapy-from-Novartis-receives-second-FDA-approval-to-treat-appropriate-r-r-patients-with-large-B-cell-lymphoma

Media Availability: Drs. Locke and Shah are available to discuss CAR T therapy. To schedule an interview, please contact Kim Polacek at 813-745-7408 or Kim.Polacek@Moffitt.org.

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999. Moffitt devotes more than 2 million square feet to research and patient care. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 5,700 team members, Moffitt has an economic impact in the state of $2.1 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on FacebookTwitter and YouTube

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