Takeda Announces FDA Approval Of sNDA for ICLUSIG® in Newly Diagnosed Ph+ ALL
Details : Iclusig (ponatinib), a kinase inhibitor, targets BCR::ABL1 for treating newly diagnosed Ph+ acute lymphoblastic leukemia in adults, in combination with chemotherapy, approved by FDA.
Brand Name : Iclusig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 19, 2024
Takeda Announces FDA Approval of sNDA for ICLUSIG® (ponatinib) in Newly Diagnosed Ph+ ALL
Details : Iclusig (ponatinib), a Tyrosine kinase inhibitor receives Supplemental New Drug Application approval by the U.S. FDA. It is indicated for adult patients with Ph+ Acute Lymphoblastic Leukemia.
Brand Name : Iclusig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 19, 2024
Details : ICLUSIG (ponatinib) is the only pan-mutational and third-generation tyrosine kinase inhibitor (TKI), targeting BCR:ABL1 and all known single, treatment-resistant mutations, including the most resistant T315I mutation.
Brand Name : Iclusig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 17, 2022
Details : The updated label includes an optimized, response-based ICLUSIG dosing regimen in CP-CML with a daily starting dose of 45 mg and, upon achieving ≤1% BCR-ABL1IS, dose reduction to 15 mg.
Brand Name : Iclusig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2020
Details : Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to Chronic Phase-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors. New Dosing Regimen Optimizes Benefit-Risk Profile, Providing Efficacy ...
Brand Name : Iclusig
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 19, 2020
Details : Data from the interim analysis of the Phase 2 OPTIC trial show that response-based dosing regimens of Iclusig can optimize benefit-risk profile in patients with resistant or intolerant chronic phase-chronic myeloid leukemia (CML).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 29, 2020
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