Washington, DC, United States (4E) – Novartis AG announced on Monday that the U.S. Food and Drug Administration (FDA) has given its leukemia treatment a Breakthrough Therapy status.
The Swiss drugmaker’s CTL019 drug, currently in the testing stage at the University of Pennsylvania’s Perelman School of Medicine, is intended to become a treatment for relapsed or refractory acute lymphoblastic leukemia, which is a rapidly worsening form of cancer that lead to abnormal white blood cells.
The FDA designation for a Breakthrough Therapy is intended to make the development and review of new drugs for serious or life-threatening conditions faster if the therapy has provided significant improvement over an available therapy on at least one major clinical endpoint.
CTL019 is part of the Basel-based pharmaceutical company’s new set of experimental treatments it is currently developing, also known as CAR therapies. They consist of a new type of immunotherapy, a method that utilizes the human body’s own immune system to battle disease, and which has become an increasingly popular area in the effort to fight cancer.