Skip to main content
Premium Trial:

Request an Annual Quote

NICE Recommends Servier's Tibsovo With Chemo for Newly Diagnosed IDH1-Mutant AML

NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Friday recommended that the National Health Service provide Servier Pharmaceuticals' Tibsovo (ivosidenib) plus chemotherapy to newly diagnosed acute myeloid leukemia patients with an IDH1 R132 mutation.

In its final draft guidance, NICE said the recommendation was based on results from the Phase III AGILE trial, which compared Tibsovo plus azacitidine against placebo plus azacitidine in previously untreated IDH1-mutant AML patients who could not have intensive induction chemotherapy. In the trial, Tibsovo plus azacitidine improved event-free and overall survival in patients versus just azacitidine.

NICE noted in the guidance that the AGILE study did not compare Tibsovo and chemo against the standard first-line chemo combination of AbbVie and Genentech's Venclexta (venetoclax) plus azacitidine. The company, therefore, conducted a cross-trial comparison to estimate the degree of benefit newly diagnosed AML patients can expect from Tibsovo-chemo versus Venclexta-azacitidine and found the analysis favored Tibsovo-azacitidine. NICE noted that the confidence intervals in the analysis crossed, however, which may indicate that there is little or no difference between the two treatments.

The list price for a 60-tablet pack of 250 mg Tibsovo is £12,500 ($15,632) or £150,000 for a year of treatment. NICE said that Servier is providing Tibsovo to the NHS at a confidential discount.

NICE said about 6 percent to 10 percent of AML patients have an IDH1 mutation, and that about 130 AML patients in England per year would be eligible for this treatment. Tibsovo will be available through the UK's Cancer Drugs Fund until NICE publishes its final guidance.

Tibsovo plus chemo is approved for newly diagnosed IDH1-mutant AML in Europe and the US. The drug is also approved as a monotherapy for advanced IDH1-mutant cholangiocarcinoma in the US and Europe and in the US for IDH1-mutant relapsed or refractory myelodysplastic syndromes.