Novartis (NVS) said Friday that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion on Scemblix for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase across all lines of treatment.

The drugmaker said the recommendation was based on results from a phase III trial that demonstrated superior major molecular response rates, fewer dose reductions, and half the rate of treatment discontinuation due to side effects compared with the investigators' choice of tyrosine kinase inhibitor treatment in patients.

The European Commission is expected to make a final decision on the CHMP recommendation within two months. If approved, Scemblix will be indicated for both newly diagnosed and previously treated adults, expanding access to four times as many patients in Europe, Novartis said.

Scemblix is already approved for earlier-line use in over 20 countries, including the US, Japan, and China, Novartis said.