Leukemia Research Foundation News

FDA Approves New Drug Combination for AML

The FDA has approved the drug combination of Tibsovo and Vidaza for patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) who are 75 years or older or have underlying health conditions that prevent them from being a candidate for chemotherapy.

According to a press release, Tibsovo is the first therapy targeting cancer metabolism approved in combination with Vidaza for this patient population.

“… Tibsovo is the first therapy targeting cancer metabolism to demonstrate an impressive, significant benefit in event-free survival and overall survival in combination with (Vidaza), underscoring its importance as part of a new combination regimen for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” said Eytan Stein, MD, director of program medicine at Memorial Sloan Kettering Cancer Center.

In clinical trials, the drug combination demonstrated a statistically significant improvement in progression-free survival (time during and after treatment when the patient lives without disease progression) and overall survival (time from treatment until death). Specifically, the median overall survival for patients taking the approved combination was 24 months compared to 7.9 months for patients taking a placebo plus Vidaza.

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