"Thumbs Up For Latest CAR T-Cell Approval" - Charles Bankhead
The approval of a second CAR T-cell therapy within 2 months signals the start of expanded investigation of the therapy in hematologic malignancies and possibly beyond. Approved by the FDA for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), axi-cel (Yescarta) enters a larger disease field as compared with tisagenlecleucel (Kymriah), which received FDA approval for children and young adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia. DLBCL is the most common form of non-Hodgkin's lymphoma (NHL) and often has an aggressive clinical course. James L.M. Ferrara, MD, DSc, professor of pediatrics, oncological sciences and medicine, hematology and medical oncology at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai called the FDA action "great news for cancer patients." The approval, he said, "proves that gene therapy is here to stay, and is likely to help increasing numbers of patients with terrible blood cancers that don't respond to standard treatments. There are highly personalized therapies, and this success will accelerate efforts to make such treatments available for large numbers of patients."
- James L.M. Ferrara, MD, DSc, Professor of Pediatrics, Oncological Sciences and Medicine, Hematology and Medical Oncology at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and Co-director of Mount Sinai Acute GVHD International Consortium (MAGIC)