Xalkori Now FDA Approved for the Treatment of ALK-Positive Inflammatory Myofibroblastic Tumor

Web Exclusives - FDA Approvals

On July 14, 2022, the FDA approved the multikinase inhibitor crizotinib (Xalkori; Pfizer) for the treatment of unresectable, recurrent, or refractory inflammatory myofibroblastic tumors with anaplastic lymphoma kinase (ALK) mutation in patients aged ≥1 years. The FDA granted crizotinib an orphan drug designation for this indication.

Crizotinib was previously approved for the treatment of patients with metastatic non–small-cell lung cancer and ALK or ROS1 mutation, and for young patients aged 1 to 21 years with relapsed or refractory systemic anaplastic large-cell lymphoma and ALK mutation.

This new indication was based on the results of 2 multicenter, single-arm, open-label clinical trials— ADVL0912 and A8081013—that enrolled patients with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors.

The ADVL0912 study included 14 pediatric patients, and 12 of these patients had an objective response to crizotinib, with an overall response rate of 86% (95% confidence interval, 57%-98%).

The A8081013 study enrolled 7 patients, 5 of whom had an objective response.

In the pediatric patients, the most common (≥35%) adverse events were vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. In the adult patients, the most common (≥35%) adverse events were vision disorders, nausea, and edema.

The recommended dose of crizotinib is 250 mg/m2 orally twice daily in adults and 280 mg/m2 orally twice daily in pediatric patients until disease progression or unacceptable adverse events.

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Last modified: August 30, 2022
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