Jorge Cortes, MD, Director at the Georgia Cancer Center discusses U.S. FDA Approves Supplemental New Drug Application for Takeda"™s ICLUSIG® (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML.
CAMBRIDGE, Mass. & OSAKA, Japan"(BUSINESS WIRE)"Takeda Pharmaceutical Company Limited (TSE:4502/NYSE: TAK) announced today that the United States has announced The supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) has been approved by the Food and Drug Administration (FDA) in adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or aversion to at least two prior kinase inhibitors. The revised label provides an integrated, response-based ICLUSIG dosing regimen in CP-CML with a starting daily dose of 45 mg and a dose reduction to 15 mg after achieving ~1% BCR-ABL1IS. By providing efficacy and reducing the risk of adverse events (AEs), like arterial occlusive events, this dosing regimen aims to optimize the gain risk (AOEs).
The sNDA approval is based on data from the OPTIC (Optimizing Ponatinib Care In CML) Phase 2 trial and on five-year data from the PACE (Ponatinib Ph+ ALL and CML Evaluation) Phase 2 trial.
The OPTIC trial included patients with CP-CML whose disease was highly resistant to their immediate prior TKI, most of whom (65%) did not respond to immediate prior therapy to a response greater than complete hematological response (CHR). At 12 months, 42 percent of 88 patients using the newly approved response-based dosing regimen (45 mg to 15 mg) achieved ~1 percent BCR-ABL1IS, the primary OPTIC endpoint, and 73 percent of these patients preserved their response at a median follow-up period of 28.5 months. In these patients, 13% had an AOE of any stage, 7% had a grade 3 or higher experience. Risk factors such as uncontrolled hypertension or diabetes should be monitored, and patients with an active or substantial history of clinically significant, uncontrolled cardiovascular disease should be treated with caution.