Yescarta FDA approval : Kite Pharma has bagged the US FDA approval for its chimeric antigen receptor T cell (CAR T) therapy Yescarta (axicabtagene ciloleucel) for a type of lymphatic cancer (Lymphoma).
FDA Approves New Lymphoma Drug Yescarta
The Car T therapy from the Gilead subsidiary will be available as a new treatment option in the United States for adult patients with relapsed or refractory large B-cell lymphoma who had received at least two lines of systemic therapy.
Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL resulting from follicular lymphoma (transformed follicular lymphoma, or TFL) can be treated for their condition with the newly approved lymphoma drug Yescarta.
However, a point to note is that the Kite Car T therapy Yescarta hasn’t been indicated for treating patients with primary central nervous system lymphatic cancer.
Gilead claims CAR T therapy to be a breakthrough in blood cancer treatment. CAR T therapy involves engineering of a patient’s own T cells to target and kill cancer cells. CAR T therapy is manufactured according to each individual patient, says Gilead Sciences.
Frederick L. Locke, the Vice Chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt Cancer Center in Tampa, commenting on the Yescarta FDA approval, said: “With CAR T therapy, we are reengineering a patient’s own immune system to detect and kill cancer cells, and the results have been impressive.
“Many of the patients that received CAR T therapy had already relapsed several times with traditional treatments such as chemotherapy or hematopoietic stem cell transplant. Now, thanks to this new therapy many patients are in remission for months.”
Commenting on the CAR T therapy FDA approval of Kite’s Yescarta, the company’s Worldwide Head of Research and Development and Chief Medical Officer David Chang said: “Engineered cell therapies like Yescarta represent the potential for a changing treatment paradigm for cancer patients.
“Together, Gilead and Kite will accelerate studies of CAR T therapy in multiple blood cancers and advance other cell therapy approaches for solid tumors, with the goal of helping patients with diverse cancers benefit from this new era of personalized cancer therapy.”
Following the Yescarta FDA approval, the newly approved lymphoma drug Yescarta will be manufactured at Kite Pharma’s facility in El Segundo, California. Yescarta lymphoma drug cost in the United States has been fixed at $373,000.
Louis J. DeGennaro, PhD, President and Chief Executive Officer of The Leukemia & Lymphoma Society commenting on the approval of Kite lymphoma drug Yescarta FDA approval, said: “This therapy is a new option for patients with relapsed or refractory large B-cell lymphoma who have run out of treatment options and face a dire prognosis.
“Early on, LLS recognized the potential of CAR T therapy and we are proud to be part of making this historic approval possible.”