FDA Approves Crizotinib for ALK+ Inflammatory Myofibroblastic Tumors

FDA

The FDA has approved crizotinib (Xalkori) for adult and pediatric patients aged 1 year and older with unresectable, recurrent, or refractory inflammatory ALK-positive myofibroblastic tumors (IMT).

The safety and efficacy of the agent were examined in the following 2 multicenter, single-arm, open-label trials: ADVL0912 (NCT00939770), which enrolled 14 pediatric patients, and A8081013 (NCT01121588), which enrolled 7 adult patients. All patients had unresectable, recurrent, or refractory ALK-positive IMT.

The major efficacy outcome measure of these trials was objective response rate (ORR). In the 14 pediatric patients, the ORR achieved with crizotinib was 86% (95% CI, 57%-98%) per independent review committee assessment. Of the 7 adult patients, 5 patients achieved objective responses with the agent.

Regarding safety, the most common toxicities experienced by pediatric patients who received crizotinib included vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. In adult patients, the most common adverse effects experienced with the agent were vision disorders, nausea, and edema.

Reference

1. FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor. News release. FDA. July 14, 2022. Accessed July 14, 2022. https://bit.ly/3uK0yze