Takeda Pharmaceutical Company Limited
U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
Saturday, December 19, 2020 2:19PM IST (8:49AM GMT)
– Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors (TKIs) –
– Approval Based on Data from the Phase 2 OPTIC Trial, Which Evaluated Response-Based ICLUSIG Dosing Regimens in CP-CML –
– New Dosing Regimen in CP-CML Optimizes Benefit-Risk Profile, Providing Efficacy and Improving Safety –
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG