FDA Grants Priority Review to Ivosidenib for IDH1-Mutant AML

The FDA granted a priority review to ivosidenib (Tibsovo) for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 mutation who are not eligible for standard therapy, according to Agios Pharmaceuticals, the drug’s manufacturer.

“In less than seven months since Tibsovo's approval in relapsed or refractory AML, we are pleased to be working with the FDA to expand its labeled indication into the frontline setting,” Chris Bowden, M.D., chief medical officer of Agios, said in a press release.

The agency set a Prescription Drug User Fee Act (PDUFA) action date of June 21, 2019.

A priority review accelerates the FDA’s review time from 10 months to a goal of 6 months from the day of a drug’s filing acceptance and is given to agents that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. In this case, ivosidenib may offer this patient population a new treatment option, Bowden explained. “Patients with newly diagnosed AML who are not eligible for standard treatments, such as intensive and non-intensive chemotherapy, are currently offered only palliative care. There is tremendous need for new treatment options, and we believe AML patients with IDH1 mutations have the potential to benefit from this targeted therapy,” he added.

Of note, the supplemental new drug application was accepted under the FDA’s Real-Time Oncology Review pilot program, which aims to make the review of oncology drugs more efficient by allowing the agency access to clinical trial data before the information is formally submitted for review.