However, the Kite Car T therapy hasn’t been indicated by the US drug regulator for treating primary central nervous system lymphoma.
Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma in adults. Around 72,000 cases of NHL are reported in the US each year, with DLBCL itself making up about one third of them.
The CAR T therapy from Kite, a subsidiary of Gilead Sciences will be customized as per the individual patient’s requirement and is available at a price of $373,000 in the US.
Gilead Sciences president and CEO John Milligan said that the FDA approval for Yescarta is an important day for relapsed or refractory large B-cell lymphoma patients who had no other options left and waiting for new treatments for their cancer.
Milligan added: “With the combined innovation, talent and drive of the Kite and Gilead teams, we will rapidly advance cell therapy research and aim to bring new options to patients with many other types of cancer.”
Yescarta is a cell-based gene therapy in which the patient’s own T cells are collected and modified genetically to induce a new gene that targets and kills the cancer cells.
According to the FDA, Yescarta is the second gene therapy it has approved and the first for certain types of non-Hodgkin lymphoma (NHL).
FDA Commissioner Scott Gottlieb said: “In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer.
“This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products.”
Image: Kite’s Yescarta has been approved for B-Cell Lymphoma in the US. Photo: courtesy of nikonlike/FreeDigitalPhotos.net.