image credit: pharmaphorum
Just three days after Syndax Pharmaceuticals revealed data from a trial of revumenib in one indication of acute leukemia which chilled investors, the FDA has approved the small molecule in another indication of the disease.
On Friday, the U.S. regulator signed off on Revuforj as the first menin inhibitor to treat a genetic type of leukemia called lysine methyltransferase 2A (KMT2A). The nod applies to patients one year and older with relapsed or refractory leukemias who have rearrangements of the KMT2A gene.
The approval came six weeks ahead of its target date and is the second FDA new drug endorsement for Syndax in the last three months. In August, Syndax and its commercial partner Incyte earned a thumbs up for Niktimvo (axatilimab), a CSF-1R inhibitor to treat chronic graft-versus-host disease (cGVHD) in patients who’ve failed at least two prior lines of systemic therapy.
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