By PPN News Staff
With the approval of tisagenlecleucel (Kymriah, Novartis), the FDA made available the first gene therapy in the United States, ushering in a new approach to the treatment of cancer and other serious diseases, the agency said.
The FDA approved tisagenlecleucel for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.