FDA approves Xalkori for ALK-positive inflammatory myofibroblastic tumors
Click Here to Manage Email Alerts
The FDA approved crizotinib for treatment of adults and children aged 1 year or older with anaplastic lymphoma kinase-positive unresectable, recurrent or refractory inflammatory myofibroblastic tumors.
Crizotinib (Xalkori, Pfizer), an ALK tyrosine kinase inhibitor, is approved for treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK positive or ROS1 positive, as well as certain patients with systemic anaplastic large cell lymphoma.
The FDA based the latest approval on results of two open-label, multicenter, single-arm trials that included patients with unresectable, recurrent or refractory ALK-positive inflammatory myofibroblastic tumors. Objective response rate served as the major efficacy outcome measure of the trials.
Among 14 pediatric patients in the ADVL0912 trial, 12 (86%; 95% CI, 57-98) had an independent review committee-assessed objective response. Among seven adults in the A8081013 trial, five demonstrated objective responses.
The most common adverse events, occurring in at least 35% of patients, included vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation and headache among pediatric patients and vision disorders, nausea and edema among adult patients.
Crizotinib is recommended at twice-daily oral doses of 250 mg for adults and 280 mg/m2 for pediatric patients until disease progression or unacceptable toxicity.
Read more about
Click Here to Manage Email Alerts