Novartis said that the Ministry of Food and Drug Safety has approved Scemblix (Ingredient: asciminib), a treatment for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Semblix treats adult patients with Ph+ CML in the chronic stages who have received treatment with two or more tyrosine kinase inhibitors (TKIs).

Novartis based the efficacy of this drug on the major molecular and cytogenetic response rates. Therefore, patients can take the drug regardless of meals with a recommended daily dose of 80 mg and should continue taking the treatment until they observe a clinical benefit or develop unacceptable toxicity.

Physicians can change the dosage based on patient care needs.

The treatment has also received approval from the U.S. Food and Drug Administration for Ph+ CML patients and T315I mutant-expressing Ph+ CML-CP patients who have received treatment with two or more TKIs based on the major molecular response rate (MMR) at week 24.

The FDA based its approval on the ASC4FIRST phase 3 clinical trial and the NCT02081378 phase 1 clinical trial.

The clinical trials found that Semblix had more than double the rate of major molecular response (MRR) at week 24 compared to Pfizer's Bosulif (Ingredient: bosutinib).