This kinase inhibitor is indicated to be used in combination with chemotherapy in adult patients with newly diagnosed Ph+ ALL.
The approval was based on the treatment regimen achieving minimal residual disease (MRD)-negative complete remission (CR) observed after induction therapy with the treatment.
The sNDA previously received priority review and was approved under the Real-Time Oncology Review (RTOR) programme.
Based on the results from the PhALLCON study, an international randomised, open-label, multicentre Phase III clinical trial, the FDA granted the approval.
It 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, showing ICLUSIG superiority over imatinib.
Subjects in the ICLUSIG arm attained over two-fold improvement in the rate of MRD-negative CR at the end of induction.
The safety profile of ICLUSIG was observed to be in line with imatinib without any new safety concerns detected during the trial.
Takeda oncology chief medical officer Awny Farajallah said: “This label expansion for ICLUSIG is an incredibly exciting milestone, allowing US adult patients with newly diagnosed Ph+ ALL to have an approved, targeted treatment option in the frontline.
“We are thrilled that the FDA has recognised 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.”