Takeda Gets Approval for sNDA for ICLUSIG

Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

Overview

ICLUSIG Becomes the First and Only Targeted Treatment Approved in the U.S. for Frontline Ph+ Acute Lymphoblastic Leukemia (ALL) in Combination with Chemotherapy

− First FDA Approval in Ph+ ALL Based on Novel Primary Endpoint of Minimal Residual Disease (MRD)-negative Complete Remission (CR)

Trial Behind Approval

• Accelerated Approval Based on Data from the Phase 3 PhALLCON Trial, in which ICLUSIG Demonstrated Superiority in MRD-negative Complete Remission Rates and Comparable Safety to Imatinib  Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. 
• This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. 
• Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 
• This accelerated approval application was granted Priority Review and evaluated under the Real-Time Oncology Review (RTOR) program, an FDA initiative designed to expedite the delivery of cancer medicines by allowing components of an application to be reviewed before submission of the complete application.

Words from CMO: Takeda

This label expansion for ICLUSIG is an incredibly exciting milestone, allowing U.S. adult patients with newly diagnosed Ph+ ALL to have an approved, targeted treatment option in the frontline,” said Awny Farajallah, MD, chief medical officer, oncology at Takeda. “We are thrilled that the FDA has recognized the potential of ICLUSIG to fill a large gap in care for these patients and look forward to seeing the impact this can have on people with this rare and aggressive form of cancer.

PhALLCON Study

• The approval was supported by data from the PhALLCON study – the first, global, Phase 3, registrational, head-to-head clinical trial in adults with newly diagnosed Ph+ ALL. 
• The study, in which patients received either ICLUSIG or imatinib, plus reduced-intensity chemotherapy, met its primary endpoint of MRD-negative CR at the end of induction. 
• MRD-negative CR is a composite endpoint defined in alignment with the FDA that reflects deep molecular and clinical responses and is an important prognostic indicator for long-term outcomes for patients with Ph+ ALL. 
• ICLUSIG demonstrated superiority compared to imatinib, with patients who received ICLUSIG achieving a greater than two-fold improvement in the rate of MRD-negative CR at the end of induction (cycle 3). 
• In the trial, the safety profile of ICLUSIG was comparable to imatinib, and no new safety signals were identified.

Lead Investigator Words on Trial

Ph+ ALL is an extremely aggressive cancer and patients with this disease suffer from poor outcomes. There has long been a need for a potent TKI that can suppress mutation development and elicit deep responses in the frontline,” said Elias Jabbour, MD, The University of Texas MD Anderson Cancer Center and lead investigator of the PhALLCON trial. “Ponatinib may help address these factors and impact long-term outcomes.

ICLUSIG

• ICLUSIG is a kinase inhibitor indicated in the U.S. for adult patients with newly diagnosed Ph+ ALL in combination with chemotherapy. 
• This indication is approved under accelerated approval based on MRD-negative CR at the end of induction. 
• Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). 
• In addition, it is approved as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL, chronic-phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors, accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated or T315I-positive CML (chronic phase, accelerated phase, or blast phase). 
• ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

About the PhALLCON Trial

The PhALLCON study is a Phase 3, randomized, international, open-label multicenter trial evaluating the efficacy and safety of ICLUSIG versus imatinib, in combination with reduced-intensity chemotherapy as a frontline therapy for adult patients with newly diagnosed Ph+ ALL.

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