Novartis reports positive data for new leukaemia drug

Novartis has announced positive results from the global phase III RATIFY clinical trial, assessing the safety and efficacy of the new leukaemia therapy PKC412.

It was shown that adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukaemia who received the investigational compound, plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival compared to those receiving standard treatment and consolidation chemotherapy alone.

This study, conducted in partnership with the Alliance for Clinical Trials in Oncology, represents the first large controlled trial to show overall survival benefit for a drug against this form of the disease.

Currently, there are no approved targeted acute myeloid leukaemia therapies available, meaning PKC412 – also known as midostaurin – could represent an important step forward.

Dr Alessandro Riva, global head of Novartis' oncology development and medical affairs business, said: "Based on the results of this trial, we plan to move forward with global regulatory submissions for PKC412 in the first half of 2016."

Cancer therapeutics are a key area of focus for Novartis, which purchased the oncology portfolio of GlaxoSmithKline last year.