Novartis Pharmaceuticals applies to Euro regulator with Glivec

Novartis is seeking marketing authorisation for its leukaemia drug Glivec.

The submission of all the necessary documents to the European regulator has been completed and the US submission is expected to be completed within the next few weeks.

If approved, Glivec would be the first therapy that specifically targets the genetic abnormality responsible for Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) and the company is looking for authorisation for use as either a single agent or in combination with chemotherapy.

Dr Diane Young, head of clinical development at Novartis Oncology, said: “Novartis is committed to pursing innovative regulatory submissions for Glivec that meet high unmet medical needs.

“This submission relies on published data generated by world leaders in the treatment of Ph+ ALL and could provide an important new treatment option in an area where standard chemotherapeutic regimens have remained essentially unchanged for a decade.”

Data submitted as a part of the application shows the drug’s use prompted two-year disease free survival of up to 87 per cent and one-year overall survival of up to 84 per cent for newly diagnosed patients when given with standard chemotherapy.

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