The US FDA Approves Novartis’ Scemblix for Newly Diagnosed Ph+ CML in Chronic Phase
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- Based on P-III (ASC4FIRST) results and preliminary data from the P-II (ASC2ESCALATE) study, the US FDA granted accelerated approval to Scemblix for adult patients with newly diagnosed Philadelphia chromosome +ve Chronic Myeloid Leukemia
- The P-III (ASC4FIRST) study (n=405) investigating Scemblix (80mg, QD) vs. IS SOC TKIs and imatinib alone at 48wks. demonstrated approx. 20% & 30% more patients treated with Scemblix achieved MMR and also showed deeper rates of molecular responses incl. MR4 vs IS SOC TKIs and imatinib respectively
- Scemblix demonstrated a positive safety, efficacy, and tolerability profile. Furthermore, the P-III (ASC4FIRST) study is currently ongoing for 96wks. to further investigate the key 2EP and additional 2EPs
Ref: Novartis | Image: Novartis
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