U.S. FDA Approves Supplemental New Drug Application for Takeda's ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
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-CM...