UK’s MHRA Authorizes Novartis’ Scemblix for Ph+ CML

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization to Novartis’ Scemblix (asciminib) for treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

The authorization is specifically for patients previously treated with two or more tyrosine kinase inhibitors (TKIs) and without a known T315I mutation. It was supported by results from a phase 3 trial in which Scemblix showed a meaningful difference in the response rate compared with bosutinib, a TKI approved for treatment of chronic myeloid leukemia.

In October 2021, the FDA granted Scemblix accelerated approval for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved it for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with the T315I mutation.