Breakthrough Designation for Novartis T-Cell Therapy Against ALL


Novartis has announced that the US Food and Drug Administration has granted Breakthrough Therapy status to CTL019, an investigative agent for patients with relapsed or refractory acute lymphoblastic leukemia in children and adults.

CTL019 is chimeric antigen receptor therapy (CART). That means that it uses CAR technology to "reprogram a patient's own T cells" to hunt down cancer cells that expess a specific protein on the cell surface known as CD19.

Once reprogrammed, the T cells (which then are called CTL019) are administered back into the patient's blood. There, they multiply and bind to the targeted CD19 positive cells and kill them.

"This Breakthrough Therapy designation underscores the potential of CTL019 as a life-saving therapy for patients with relapsed/refractory ALL, who are in desperate need of new treatment options," said David Epstein, Division Head, Novartis Pharmaceuticals.

"Novartis welcomes increased dialogue with the FDA and a potentially expedited review to streamline the development of CTL019 and hopefully bring this promising therapy to patients as quickly as possible."

Safety and efficacy have not been established yet for this agent.

Source: Novartis

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