FDA approves Novartis' latest leukemia treatment

Nov. 1, 2021

The U.S. FDA has approved Novartis’ Scemblix for two indications in chronic myeloid leukemia.

The agency granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors, based on major molecular response rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation.

According to Novartis, Scemblix, a first-in-class STAMP inhibitor, provides a much-needed and long-awaited new option for patients with chronic myeloid leukemia who suffer from intolerance or inadequate response after at least two previous tyrosine kinase inhibitor treatments.

Back in Nov. 2020, as part of an annual investor presentation, Novartis CEO Vasant Narasimhan had outlined five experimental "wild card" treatments covering a range of drug classes that the company said the offer "high-risk, high reward" opportunities in the years ahead — and Scemblix had been among them. The approval now joins Tasigna and Gleevac in Novartis' powerful CML portfolio.