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Novartis nets first acute myeloid leukaemia approval in Canada, but NICE says no

Published on 06/12/17 at 10:04am

Novartis is celebrating the news that its drug Rydapt (midostaurin) has been awarded marketing approval in Canada for the treatment of FLT3-mutated acute myeloid leukaemia (AML) following a priority review by the country’s governmental department responsible for drug regulation, Health Canada. However, the firm faces complications on the other side of the Atlantic, as NICE saw fit to reject the treatment for use on the NHS in the same indication.

FLT3-mutated AML is the most common gene mutation in the disease, occurring in around 37% of cases.

Health Canada’s approval covers the use of Rydapt in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy. The decision was based on Phase 3 trial data which demonstrated that patients who took the drug in addition to chemotherapy lived for longer than those receiving chemotherapy alone.  

"We are very pleased to bring the first targeted therapy to AML patients with the FLT3 mutation. There has been a long gap in development of innovative therapies for this serious blood cancer and this advance represents new hope for these patients," said Winselow Tucker, General Manager of Oncology Business Unit of Novartis Pharmaceuticals Canada Inc. "The arrival of Rydapt in Canada is a result of our commitment to developing important new therapies for Canadians with blood and other types of cancers."

NICE, however, noted that the efficacy of Rydapt in patients over 60 is uncertain, as the trial did not include any participants from this age group. The watchdog knocked back the drug as it claimed it “does not have plausible potential to be cost effective at its current price and more clinical data collection would not address the uncertainties.”

“There is also considerable uncertainty about the cost effectiveness of midostaurin because of problems with the economic model,” NICE said. “These include not accounting properly for remission after relapse and including implausibly high long-term costs in some situations.”

Matt Fellows

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