Yescarta CAR-T Therapy Approved for B-Cell Lymphoma
October 19, 2017 – The U.S. FDA has approved Yescarta™ (axicabtagene ciloleucel), manufactured by Kite, to treat adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma—after trying at least two other lines of systemic therapy.
B-cell lymphomas are blood cancers that begin in the lymph nodes. They include both Hodgkin’s lymphomas and non-Hodgkin’s lymphomas (NHL), and can range from slow-growing to aggressive forms. The prognosis for patients with B-cell lymphomas is based on the type and stage of cancer. Diffuse large B-cell lymphoma is the most common type of NHL in adults, accounting for approximately one-third of new NHL diagnoses each year in the United States. It is typically an aggressive cancer, most often diagnosed in older patients.
The second CAR-T therapy to be approved in the U.S., Yescarta is made by harvesting the patient’s own T cells, a type of immune cell, and modifying them to specifically target and destroy B-cell lymphoma through the CD19 proteins found on the cancer cells’ surfaces. The modified cells are ready for infusion back into the patient after about three weeks’ processing time, and may remain effective long enough to prevent or delay recurrence of the lymphoma. Patients who receive Yescarta must receive pretreatment with chemotherapy. They must also be monitored for side effects for at least one week following infusion.
Yescarta has a risk evaluation and mitigation strategy (REMS), and carries a black box warning cautioning patients of the risk of severe or fatal cytokine release syndrome (CRS) and neurologic toxicity. Other potential side effects include low blood cell counts, a weakened immune system, and risk of serious infection. In the event of a cytokine release storm, patients can be treated with Genentech’s Actemra® (tocilizumab), which is required to be kept on hand at facilities where Yescarta is administered. The new CAR-T therapy can only be administered at certified healthcare facilities by professionals specially trained to treat Yescarta patients, including monitoring for and treating potential side effects.
Kymriah™, manufactured by Novartis and launched in September, was the first CAR-T therapy to receive U.S. FDA approval. Unlike Yescarta, it is indicated to treat patients under 25 years of age who have B-cell acute lymphoblastic leukemia (ALL) and have relapsed at least twice or no longer respond to standard treatments.
Kite, which was acquired by Gilead earlier this year, has already launched Yescarta. The product has an estimated cost of $373,000.
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