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May 26, 2022

FDA approves Servier’s Tibsovo-azacitidine combo therapy for AML

The latest approval is based on findings from a Phase III AGILE clinical trial of Tibsovo plus azacytidine in AML patients.

The US Food and Drug Administration (FDA) has granted approval for Servier Pharmaceuticals’ Tibsovo (ivosidenib tablets) plus azacitidine to treat patients with recently diagnosed IDH1-mutated acute myeloid leukaemia (AML).

The combination treatment is indicated for use in adult patients aged 75 years or above, or those who have comorbidities that prevent the usage of intensive induction chemotherapy.

Once a day 500mg oral dose of Tibsovo is recommended for newly diagnosed IDH1-mutated AML.

Tibsovo is claimed to be the first therapy that acts on cancer metabolism to receive approval along with azacitidine for these AML patients.

The latest expanded approval from the regulatory agency is based on findings from the international Phase III AGILE clinical trial in recently diagnosed IDH1-mutated AML patients who are not eligible for intensive chemotherapy.

In the trial, Tibsovo plus azacitidine showed a statistically significant improvement in event-free survival and overall survival.

Furthermore, the combination treatment as first-line therapy for IDH1-mutated AML provided a threefold improvement in median OS of 24 months versus 7.9 months in the placebo plus azacitidine arm.

The safety profile of Tibsovo plus azacitidine in the trial was in line with priorly reported data. 

Tibsovo is already approved in the US as monotherapy to treat IDH1-mutant relapsed or refractory AML adult patients.

Servier Pharmaceuticals CEO David Lee said: “The approval builds on the established body of evidence for Tibsovo, which is now approved across multiple IDH1-mutated cancer types.

“As a leader in oncology pioneering the science behind targeted IDH inhibition, we are proud to bring a new therapeutic option to the acute myeloid leukaemia community and remain committed to pushing the boundaries of healthcare innovation in oncology and beyond.”

A cancer of blood and bone marrow, AML is characterised by quick progression of the disease.

In December 2020, the company entered an agreement to acquire Agios Pharmaceuticals’ oncology business for up to $2bn.

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