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Agios' blood cancer combo therapy gains US FDA's breakthrough designation

Agios Pharmaceuticals Inc. has been granted the U.S. Food and Drug Administration's breakthrough therapy status for a combination therapy including its drug Tibsovo to treat patients with a certain type of blood cancer.

Tibsovo, or ivosidenib, in combination with Celgene Corp.'s Vidaza, or azacitidine, is aimed at treating newly diagnosed acute myeloid leukemia patients with a mutation called isocitrate dehydrogenase 1, or IDH1. The therapy was granted the breakthrough designation in the treatment of patients aged 75 years or older, who have additional conditions that prevent the use of chemotherapy.

Acute myeloid leukemia is a type of cancer in which too many immature white blood cells known as myeloblasts occur in the bone marrow and blood. This kind of cancer usually begins in the bone marrow and spreads into the blood. IDH1 is an enzyme that is encoded by the IDH1 gene on chromosomes.

The FDA's breakthrough therapy status expedites the development and review of drugs meant to treat serious or life-threatening conditions based on evidence indicating that the drug may show substantial improvement over available therapies.

Patients with newly diagnosed acute myeloid leukemia who cannot undergo chemotherapy are offered palliative care, according to Agios Chief Medical Officer Chris Bowden.

"Outcomes for newly diagnosed AML patients ineligible for intensive chemotherapy are still poor, and there are no approved options specifically for patients with an IDH1 mutation," Bowden said in the company's March 26 release.

In February, the FDA accepted Agios' application seeking expanded approval for Tibsovo in the treatment of patients with acute myeloid leukemia with IDH1 that has returned or is unresponsive to treatment.

Previously, Agios said Tibsovo showed treatment benefits in two of its studies — a phase 1/2 study and phase 1 study — for certain acute myeloid leukemia patients.

Tibsovo was approved by the agency in July 2018 as a treatment for acute myeloid leukemia with IDH1 that has returned or is unresponsive to treatment.