FDA Grants Priority Review to Tibsovo for Acute Myeloid Leukemia Subgroup

The Food and Drug Administration (FDA) granted a priority review to Tibsovo (ivosidenib) 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.

A priority review accelerates the FDA’s review time from 10 months to a goal of six 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.

Bowden went on to explain the significance of finding a treatment option for this patient population. “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.

The agency is set to make a decision by June 21, 2019.