FDA News

FDA grants fast track status to AG-120 for IDH1-mutated AML

The FDA today granted fast track status to AG-120 for patients with acute myelogenous leukemia who harbor an IDH1 mutation, according to a press release from the drug’s manufacturer.

AG-120 (Agios) is currently under evaluation in two phase 1 trials, one in hematologic malignancies and the other in solid tumors, including glioma. The trial of AG-120 in hematologic malignancies recently initiated three expansion cohorts.

"We are pleased that now both AG-120 and AG-221 have been granted fast track designation, demonstrating the FDA's commitment to facilitate the development and expedite the review of our lead IDH programs as important new therapies for people with AML who carry these mutations," Chris Bowden, MD, chief medical officer of Agios, said in a press release. "We look forward to presenting new data from the ongoing phase 1 study at the [European Hematology Association] Annual Congress next month and remain on track to initiate a global, registration-enabling phase 3 study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016."

The FDA today granted fast track status to AG-120 for patients with acute myelogenous leukemia who harbor an IDH1 mutation, according to a press release from the drug’s manufacturer.

AG-120 (Agios) is currently under evaluation in two phase 1 trials, one in hematologic malignancies and the other in solid tumors, including glioma. The trial of AG-120 in hematologic malignancies recently initiated three expansion cohorts.

"We are pleased that now both AG-120 and AG-221 have been granted fast track designation, demonstrating the FDA's commitment to facilitate the development and expedite the review of our lead IDH programs as important new therapies for people with AML who carry these mutations," Chris Bowden, MD, chief medical officer of Agios, said in a press release. "We look forward to presenting new data from the ongoing phase 1 study at the [European Hematology Association] Annual Congress next month and remain on track to initiate a global, registration-enabling phase 3 study in collaboration with Celgene in AML patients who harbor an IDH1 mutation in the first half of 2016."