Published: 24 Jul 2020
The U.S. Food and Drug Administration approved Tecartus (brexucabtagene
autoleucel), a cell-based gene therapy for treatment of adult patients
diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have
relapsed following other kinds of treatment. Tecartus, a chimeric antigen
receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by
the FDA for the treatment of MCL.
“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, M.D., Ph.D., 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.”
MCL is a rare form of cancerous B-cell non-Hodgkin’s lymphoma that usually
occurs in middle-aged or older adults. In patients with MCL, B-cells, a type of
white blood cell which help the body fight infection, change into cancer cells
that start to form tumors in the lymph nodes and quickly spread to other areas
of the body.
Source: www.fda.gov