Novartis leukaemia drug to get priority review from the FDA

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A new leukaemia treatment from Novartis for children and young adults will get priority review from the US Food and Drug Administration (FDA), putting the Swiss drug-maker ahead of rivals working on similar cancer therapies, reports Reuters Health.

The FDA’s announcement means the regulator plans to take action within six months on Novartis’s so-called chimeric antigen receptor T cell therapy, or CAR-T, in partnership with University of Pennsylvania researchers. The medicine, called CTL019, is a treatment for young patients with B-cell acute lymphoblastic leukaemia.

The report says the therapy involves taking a patient’s own T-cells, altering them in the lab to help the immune system find and kill cancer cells, and then re-infusing them into the patient.

Basel-based Novartis is now in pole position with regulators as it pushes for approval alongside rivals including biotech Kite Pharma Inc that are developing similar therapies.

“With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options,” Vas Narasimhan, Novartis head of drug development, is quoted in the report as saying.

In a Phase II study, Novartis said 82% of patients infused with CAR-T cells achieved complete remission or complete remission with incomplete blood count recovery at three months after treatment. In December, Novartis estimated 60 percent of those responders were relapse-free after six months.

The report says the company plans to submit an application for market authorisation with the European Medicines Agency later this year. It also plans eventually to seek approval for CTL019 to be used in patients with certain types of relapsed or refractory non-Hodgkin lymphoma, another type of blood cancer.

Reuters Health report

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