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Home Industry News Novartis receives EU approval for cancer drug Rydapt

Novartis receives EU approval for cancer drug Rydapt

21st September 2017

Novartis has announced that its cancer therapy Rydapt has been approved in Europe for the treatment of two forms of rare cancer that are difficult to treat.

The European Commission has ratified Rydapt for use in the treatment of adults with newly diagnosed acute myeloid leukaemia who are FLT3 mutation-positive, as well as for aggressive systemic mastocytosis, systemic mastocytosis with associated haematological neoplasm, or mast cell leukaemia.

It represents the first and only targeted treatment for this type of acute myeloid leukaemia and the only treatment for three subtypes of systemic mastocytosis, conditions that are typically associated with limited life expectancy and few treatment options.

This approval was based on positive safety and efficacy data from the largest landmark trials in acute myeloid leukaemia and advanced systemic mastocytosis conducted to date.

Bruno Strigini, chief executive officer for Novartis Oncology, said: "Novartis is proud that we can deliver Rydapt, a breakthrough medicine, to patients with serious and hard-to-treat diseases where there are few treatment options."

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