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Details:
Iclusig (ponatinib) is a kinase inhibitor targeting BCR::ABL1. It is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Iclusig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 19, 2024
Details:
Iclusig (ponatinib), a Tyrosine kinase inhibitor receives Supplemental New Drug Application approval by the U.S. FDA. It is indicated for the treatment of adult patients with Ph+ Acute Lymphoblastic Leukemia.
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Iclusig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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.
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Iclusig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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.
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Iclusig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 & Improving Safety.
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Iclusig
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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).
Lead Product(s): Ponatinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 29, 2020
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