The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Xalkori (crizotinib) for patients between the ages of 1 and 21 years of age with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.

The latest development derives largely from results of Study ADVL0912, which showed crizotinib treatment resulted in an objective response rate of 88%, and a complete remission rate of 81%. The safety and efficacy of crizotinib have not been established in older adults with the same condition.

ALCL is a rare type of Non-Hodgkins lymphoma that involves abnormal growth of white blood cells, either T cells or B cells. Anaplastic large cell lymphoma is an aggressive cancer that usually involves the T-cells.

The study included 26 patients with relapsed or refractory, systemic ALK-positive ALCL who had at least one systemic treatment. Patients received crizotinib 280 mg/m2 (20 patients) or 165 mg/m2 (6 patients) orally twice daily until disease progression or unacceptable toxicity. Patients were permitted to discontinue crizotinib to undergo hematopoietic stem cell transplantation. Of the 23 patients who achieved a response, 39% maintained response for at least 6 months, and 22% maintained response for at least 12 months.

The most common adverse reactions (≥35%), excluding laboratory abnormalities, were diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough, and pruritus. Grade 3-4 laboratory abnormalities (≥15%) were neutropenia, lymphopenia, and thrombocytopenia.

The recommended crizotinib dosage for systemic ALCL is 280 mg/m2 orally twice daily based on body surface area. Complete prescribing information can be found here.

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