FDA Approves Novartis' Scemblix In Two Chronic Myeloid Leukemia Settings

The FDA has approved Novartis AG's NVS Scemblix (asciminib) for chronic myeloid leukemia (CML) in two distinct indications.
The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs).
The agency granted full approval to the drug for adult patients with Ph+ CML-CP with the T315I mutation.
The approval is based on Phase 3 ASCEMBL and Phase 1 trials that showed Scemblix nearly doubled the major molecular response rate vs. Pfizer Inc's PFE Bosulif (bosutinib) at 24 weeks (25% vs. 13%).
The proportion of patients who discontinued treatment due to adverse reactions was more than three times lower in the Scemblix arm (n = 156) vs. patients in the Bosulif arm (n = 76) (7% vs. 25%).
Related content: Benzinga's Full FDA Calendar.
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