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NICE Endorses Tibsovo Plus Chemotherapy for Newly Diagnosed IDH1-Mutant AML

NextEdge Admin

11 May 2024

2 min 40 sec

The UK’s National Institute for Health and Care Excellence (NICE) has recommended the use of Servier Pharmaceuticals’ Tibsovo (ivosidenib) in combination with chemotherapy for newly diagnosed acute myeloid leukemia (AML) patients carrying an IDH1 R132 mutation. This recommendation is based on findings from the Phase III AGILE trial, which compared Tibsovo plus azacitidine against a placebo plus azacitidine for previously untreated IDH1-mutant AML patients ineligible for intensive induction chemotherapy. The study demonstrated that Tibsovo plus azacitidine improved both event-free and overall survival compared to azacitidine alone.

However, it’s worth noting that the AGILE trial did not directly compare Tibsovo plus chemotherapy with the standard first-line chemotherapy combination of AbbVie and Genentech’s Venclexta (venetoclax) plus azacitidine. To address this, Servier conducted a cross-trial comparison, which suggested a benefit for Tibsovo-azacitidine over Venclexta-azacitidine. Nonetheless, NICE cautioned that the confidence intervals in this analysis overlapped, indicating little or no difference between the two treatments.

Tibsovo comes at a list price of £12,500 ($15,632) for a 60-tablet pack of 250 mg, amounting to £150,000 for a year of treatment. However, Servier has offered a confidential discount to the NHS. Given that 6% to 10% of AML patients carry an IDH1 mutation, roughly 130 AML patients in England annually would be eligible for this treatment. Tibsovo will be accessible through the UK’s Cancer Drugs Fund until NICE publishes its final guidance.

In addition to its approval for newly diagnosed IDH1-mutant AML in Europe and the US, Tibsovo is also sanctioned as a monotherapy for advanced IDH1-mutant cholangiocarcinoma in both regions, and in the US specifically for IDH1-mutant relapsed or refractory myelodysplastic syndromes.