Crizotinib Approved for Relapsed/Refractory Systemic ALCL

Crizotinib has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children older than one year and young adults with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

This decision was based on results from Study ADVL0912, in which 26 patients between the ages of one and 21 received crizotinib 280 mg/m2 or 165 mg/m2 orally twice daily until disease progression or unacceptable toxicity. Patients were permitted to discontinue crizotinib to undergo hematopoietic cell transplantation.

The complete remission rate was 81%, with an objective response rate of 88%. Of the 23 patients who responded to therapy, 39% maintained response for at least six months, and 22% for at least one year.

Gastrointestinal toxicity occurred in 92% of patients, and ocular toxicity occurred in 65%. The most common adverse events (AEs), occurring in ≥35% of patients, included diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3-4 laboratory abnormalities that occurred in ≥15% of patients were neutropenia, lymphopenia, and thrombocytopenia.

Source:, January 14, 2021.