FDA Approves Novartis' Scemblix In Two Chronic Myeloid Leukemia Settings
- The FDA has approved Novartis AG's (NYSE: 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 (NYSE: 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.
- Price Action: NVS shares are up 1.43% at $83.94 during the premarket session on the last check Monday.
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