Tuesday, April 16, 2024

Acute Lymphoblastic Leukemia Treatment ICLUSIG Granted FDA Approval to Use in Combination with Chemotherapy

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The kinase inhibitor, ICLUSIG, has been approved for use in combination with chemotherapy for adult patients newly diagnosed with Ph+ acute lymphoblastic leukemia (ALL) by the FDA. This approval was made based on the treatment regimen achieving minimal residual disease (MRD)-negative complete remission (CR) observed after induction therapy with the treatment. The sNDA that led to this decision previously received priority review and was approved under the Real-Time Oncology Review (RTOR) program.

This approval by the FDA is based on the results from the PhALLCON study, an international randomized, open-label, multicentre Phase III clinical trial. The study compared the efficacy and safety of ICLUSIG plus low-intensity chemotherapy against imatinib plus chemotherapy in 245 subjects. The trial met the primary endpoint of attaining MRD-negative CR at the end of induction therapy, thereby demonstrating ICLUSIG’s superiority over imatinib.

ICLUSIG Achieves Breakthrough in Acute Lymphoblastic Leukemia Treatment: New Horizons in Cancer Care

Subjects in the ICLUSIG arm showed a two-fold improvement in the rate of MRD-negative CR at the end of induction. Moreover, the safety profile of ICLUSIG was observed to be in line with imatinib, and no new safety concerns were detected during the trial.

Takeda oncology chief medical officer Awny Farajallah expressed excitement over the label expansion for ICLUSIG, stating that it allows US adult patients with newly diagnosed Ph+ acute lymphoblastic leukemia to have an approved, targeted treatment option in the frontline. Farajallah expressed thrill over the FDA recognizing the potential of ICLUSIG to fill a large gap in care for these patients.

Acute Lymphoblastic Leukemia

ICLUSIG’s Approval Marks a Milestone in Treating Rare, Aggressive Cancer

This approval is significant as it offers a new treatment option for a rare and aggressive form of cancer. The approval presents a significant milestone for Takeda, and there is anticipation about the impact this could have on people with this rare and aggressive form of cancer.

Overall, the approval of ICLUSIG for the treatment of Ph+ acute lymphoblastic leukemia showcases the drug’s efficacy and safety, as evidenced by its successful results in a Phase III clinical trial and its alignment with the safety profile of imatinib. This presents a new, targeted treatment option for patients newly diagnosed with this aggressive form of cancer and fills a significant gap in patient care.

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