Last week the FDA approved their first Cell & Gene Therapy drug for the treatment of acute lymphoblastic leukemia (ALL).
I have recently written posts about new breakthroughs in the ATMP space, and the excitement around new treatments for life threatening illnesses, this just cements the development of new products such as Cell & Gene therapy and how this will impact of patient's lives.
I for one hope we can see more medicines getting approval in the US, UK & RoW.
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," said FDA Commissioner Scott Gottlieb, M.D. "New technologies such as gene and cell therapies hold out the potential to transform medicine and create an inflection point in our ability to treat and even cure many intractable illnesses. At the FDA, we're committed to helping expedite the development and review of groundbreaking treatments that have the potential to be life-saving."