Approved three years ago as a solo agent for certain patients with IDH1-mutated acute myeloid leukemia, Servier’s Tibsovo has now scored a wider indication as the company works to expand its use.
In signing off on Tibsovo in combination with Bristol Myers Squibb’s chemotherapy drug Vidaza, the FDA has cleared the way for expanded use of Servier’s oral treatment in the first-line setting. The combo can now be provided to previously untreated patients 75 and older—or those who have comorbidities that preclude the use of induction chemotherapy.
The blessing is further evidence that privately-held Servier made a smart buy last April when it acquired Agios Pharma’s oncology assets—led by Tibsovo—for $1.8 billion. The drug won its original FDA approval as a solo agent for previously treated IDH1-mutated acute myeloid leukemia patients and for those newly diagnosed with the blood disorder who are not eligible for induction chemotherapy
“Today’s approval builds on the established body of evidence for Tibsovo, which is now approved across multiple IDH1-mutated cancer types,” Servier’s CEO David Lee said in a release.
The approval is based on a phase 3 trial that investigators halted early because of striking efficacy signs. In the study of 146 patients, Tibsovo and Vidaza routed Vidaza alone in both overall and event-free survival.
The median overall survival time for patients on the combo was 24 months versus 8 months for those on Vidaza alone. Complete remission was seen in 47% of patients on the combo as opposed to 15% on Vidaza.
AML is a difficult-to-treat cancer of the blood and bone marrow which strikes roughly 20,000 in the U.S. each year. IDH1 mutations present in 6% to 10% of patients.
Last August, Tibsovo gained its first approval in a non-hematologic malignancy for patients with previously treated IDH1-mutated cholangiocarcinoma.