FDA Approves Crizotinib for Treatment of ALK+ Inflammatory Advanced Myofibroblastic Tumors

Patients with ALK-positive inflammatory myofibroblastic tumors can now receive treatment with crizotinib following the agent’s approval by the FDA.

Crizotinib (Xalkori) has received approval from the FDA for the treatment of patients with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumors who are 1 year of age or older, according to a press release from the FDA.

The agent was evaluated in multiple clinical trials, including the phase 1/2 ADVL912 trial (NCT00939770) in a younger population of patients with relapsed/refractory solid tumors or anaplastic large cell lymphoma (n = 14), as well as the phase 1 A8081013 trial (NCT01121588) in adult patients solid ALK-positive malignancies with the exception of non–small cell lung cancer (n = 7). The oral drug can be administered at a recommended dose of 250 mg twice daily in adults and 280 mg/m2 twice daily in pediatric patients until progression or unacceptable toxicity.

The overall response rate was 86% (95% CI, 57%-98%) in the ADVL912 trial, with 5 of 7 patients in the A8081013 trial experiencing objective responses. Common adverse effects (AEs) in the pediatric population included vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache, with common AEs in the adult population consisting of vision disorders, nausea, and edema.


FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor. News release. FDA. July 14, 2022. Accessed July 14, 2022. https://bit.ly/3o10Eij