Takeda announces FDA approval for ICLUSIG® in new Ph+ ALL.

Takeda (TSE:4502/NYSE:TAK) announced today that the FDA has approved ICLUSIG® (ponatinib) through sNDA for treating adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. The approval is based on accelerated approval criteria, with confirmation pending from a follow-up study to assess clinical benefits. This application was given priority review under the Real-Time Oncology Review (RTOR) program, aimed at expediting cancer medicine delivery by pre-reviewing application components before the full submission.

Takeda (TSE:4502/NYSE:TAK) has announced a significant milestone with the FDA’s approval of ICLUSIG® (ponatinib) for newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults. Dr. Awny Farajallah, Chief Medical Officer, Oncology at Takeda, expressed excitement about this approval expansion, highlighting the potential of ICLUSIG to fill a critical gap in patient care.

The FDA’s decision was based on data from the PhALLCON trial, the first global pivotal Phase 3 clinical trial for this patient population. In this trial, ICLUSIG demonstrated superiority over imatinib, showing more than a 2-fold improvement in achieving MRD-negative complete remission (CR) at the end of induction. This milestone reflects a significant molecular and clinical response, crucial for long-term treatment outcomes in Ph+ ALL patients.

Dr. Elias Jabbour from the University of Texas MD Anderson Cancer Center, the principal investigator of the PhALLCON study, emphasized the urgent need for effective treatments in the face of this aggressive cancer type. Ponatinib’s potential to suppress mutations and achieve profound responses offers hope for improving long-term outcomes.

ICLUSIG is now approved for use in combination with chemotherapy as a first-line treatment for adult patients with newly diagnosed Ph+ ALL, under accelerated approval criteria. The extension of this approval depends on the confirmation of clinical benefits in future studies. Additionally, ICLUSIG has indications as monotherapy for various phases of chronic myeloid leukemia (CML) and specific Ph+ ALL cases, addressing critical unmet medical needs in these patient populations.

The PhALLCON study, a Phase 3 trial evaluating ICLUSIG’s efficacy and safety compared to imatinib in newly diagnosed Ph+ ALL adults, has paved the way for this expanded approval. The study included 245 patients and demonstrated positive outcomes with ICLUSIG.

Ph+ ALL is a rare and aggressive form of leukemia, affecting about 25% of adult ALL patients in the United States. The approval of ICLUSIG represents a significant advancement in the treatment landscape for these patients, offering a targeted therapy option with the potential for improved outcomes and better quality of life.

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