FDA approves Kite Pharma’s Tecartus

A new cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma who have not responded to or who have relapsed following other kinds of treatment, will soon be available.

The Food and Drug Administration has given its blessing to Kite Pharma’s Tecartus, a chimeric antigen receptor T cell therapy.

The product is the first cell-based gene therapy approved by the FDA for the treatment of mantle cell lymphoma.

"Tremendous progress has been made in the discovery of new therapies for debilitating diseases that are difficult to treat. This approval is yet another example of customized treatments that use a patient's own immune system to help fight cancer, while using a scientific advance in this promising new area of medicine," said Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "We're seeing continued advances in the field of gene therapy and remain committed to supporting innovation in this promising new area of medicine."