FDA approves Xalkori for lymphoma subset
The FDA approved crizotinib for treatment of certain patients with systemic anaplastic large cell lymphoma.
The approval applies to the use of the agent for children aged 1 year or older and young adults with relapsed or refractory ALK-positive disease.
The FDA previously granted priority review to crizotinib (Xalkori; Pfizer, EMD Serono) for this indication.
Crizotinib — an ALK tyrosine kinase inhibitor — also is approved for treatment of patients with metastatic non-small cell lung cancer whose tumors are ALK positive or ROS1 positive.
The FDA based the new indication on results of the multicenter, open-label, single-arm Study ADVL0912.
The study included 26 patients aged 1 to 21 years with relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma who received at least one systemic treatment.
Patients received crizotinib dosed at 280 mg/m2 (n = 20) or 165 mg/m2 (n = 6) orally twice daily. Treatment continued until disease progression or unacceptable toxicity. Patients had the option to discontinue crizotinib treatment and undergo hematopoietic stem cell transplantation.
An independent review committee calculated an objective response rate of 88% (95% CI, 71-96) and an 81% complete remission rate.
Twenty-three patients achieved response to therapy; of these, 39% maintained response for at least 6 months, and 22% maintained response for at least 12 months.
The majority of patients (92%) developed gastrointestinal toxicity and 65% developed grade 1 or grade 2 ocular toxicity. About one-third (35%) of patients experienced serious adverse reactions, most frequently from infection or neutropenia.
The most common adverse events — excluding laboratory abnormalities — included diarrhea, vomiting, nausea, vision disorder, headache, musculoskeletal pain, stomatitis, fatigue, decreased appetite, pyrexia, abdominal pain, cough and pruritus. Grade 3 or grade 4 laboratory abnormalities reported among at least 15% of patients included neutropenia, lymphopenia and thrombocytopenia.
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