Novartis’ Kymriah receives accelerated review status in US and Europe

Novartis has announced that its cancer drug Kymriah will be assessed by regulators in the US and EU under an accelerated timescale.

The company's supplemental biologics licence application for Kymriah has been accepted for priority review by the US Food and Drug Administration, while the European Medicines Agency has also granted accelerated assessment to the drug's marketing authorisation application.

Kymriah is a suspension-based therapy for intravenous infusion among adult patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

In Europe, it is also being assessed for the treatment of children and young adults with B-cell acute lymphoblastic leukaemia (ALL). If approved it would become the first chimeric antigen receptor T cell therapy available for two distinct indications in non-Hodgkin lymphoma and B-cell ALL.

Dr Samit Hirawat, head of Novartis Oncology's global drug development operations, said: "We are now focused on working with these regulatory agencies to bring this potentially transformative therapy to more patients."

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