medwireNews: The US FDA has expanded the indication for nilotinib to include pediatric chronic myeloid leukemia (CML) patients and for blinatumomab to include adults and children with B-cell acute lymphoblastic leukemia (ALL) who are in remission but have minimal residual disease.
Nilotinib can now be given to children aged 1 year or older with Philadelphia chromosome-positive CML in the chronic phase, either for a new diagnosis or following the development of intolerance or resistance to previous tyrosine kinase inhibitors (TKIs). The previous approval was for adults with treatment-naïve, or TKI-intolerant or resistant CML.
The recommended dose for children is 230 mg/m2 twice a day, rounded to the nearest 50 mg dose, such that a single dose is no higher than 400 mg.
The approval is based on the results of the single-arm phase I CAMN107A2120 and phase II CAMN107A2203 trials.
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Blinatumomab has been granted accelerated approval for use in adult and pediatric patients with precursor B-cell ALL in first or second complete remission, with minimal residual disease of at least 0.1%.
Previously the bispecific monoclonal antibody construct was indicated for patients with relapsed or refractory disease.
The decision follows the phase II BLAST trial, in which undetectable minimal residual disease was achieved by 85% of 52 participants in first complete remission and by 72% of 18 in second complete remission after one cycle of blinatumomab therapy. The corresponding durations of hematologic relapse-free survival were 35.2 and 12.3 months.
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