"Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies". It's diagnosed in about 72,000 people each year, although just a fraction of these would be eligible for the new therapy. The indication includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma). The FDA cautions that the drug is not indicated to treat patients with primary central nervous system lymphoma. He said FDA "will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine". Moffitt has been working with CAR-T since 2015, helping run clinical trials for Kite Pharma, the company that developed Yescarta that has since been acquired by Gilead Sciences.
The new company, known as Kite, a Gilead Company, intends to add 200 jobs to the 700 it already employs at its Los Angeles-area facilities, company officials said. For the therapy, patients' T cells are collected and modified to include a gene that kills lymphoma cells, according to the release. After the cells are modified, they are infused back into the patient, where they patrol for years.
Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy".
The new treatment, Yescarta (axicabtagene ciloleucel), is for a kind of blood cancer called large B-cell lymphoma.
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"The FDA approval of Yescarta is a landmark for patients" who qualify for the treatment, which is aimed at patients with the non-Hodgkin's form of the blood cancer who had other unsuccessful treatments, Kite founder Dr. Arie Belldegrun said in a statement. The FDA warns that axicabtagene ciloleucel has a boxed warning for cytokine release syndrome, which causes a high fever, flu symptoms, and neurological toxicities. Serious adverse reactions occurred in 52% of patients and included CRS, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia, and anemia), and serious infections. The Novartis gene therapy, given the regulatory nod in August, is administered to attack child leukaemia.
"The FDA is requiring that hospitals and their associated clinics that dispense Yescarta be specially certified". The manufacturer aims to train up to 90 centers about the drug.
The new drug is made by California-based Kite, a subsidiary of drug giant Gilead Sciences that develops chimeric antigen receptor and T-cell receptor (CAR-T) cell therapies.
American regulators granted approval on Wednesday to a gene-altering treatment for patients suffering from lymphoma, the second-ever approval for a gene therapy procedure and one that could revolutionize how we fight cancer.