On 14 January 2021, crizotinib received Food and Drug Administration (FDA) approval for pediatrics one year of age and older and young individuals suffering from refractory or relapsed, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. ALCL is one of the morphologic variants of diffuse large B cell lymphoma (DLBCL). Crizotinib’s efficacy and safety have not been established in older adults having refractory or relapsed, systemic ALK-positive ALCL.
The efficacy was determined in an open-label, multicenter, single-arm trial (ADVL0912) in patients one to ≤21 years of age that incorporated 26 subjects having relapsed or refractory, systemic ALK-positive ALCL after at least one systemic therapy. Subjects were given crizotinib 280 mg/m2 (20 participants) or 165 mg/m2 (6 participants) orally twice daily until the advancement of disease or intolerable toxicity. Individuals were allowed to discontinue crizotinib to undergo hematopoietic stem cell transplantation.
The duration of response was evaluated by a review committee. Efficacy was noted on objective response rate (ORR). ORR in the 26 participants was found to be 88%, with a complete remission rate of about 81%. Out of the 23 subjects who attained a response, about 22% maintained response for at least twelve months and 39% maintained response for at least six months.
Ocular toxicity was found to occur in 65% of ALCL subjects, gastrointestinal toxicity in 92%, and serious adverse reactions in 35% (most often from infection and neutropenia). The most frequently occurring side effects (≥35%), excluding laboratory abnormalities, were headache, fatigue, diarrhea, pruritus, vomiting, decreased appetite, nausea, vision disorder, cough, musculoskeletal pain, abdominal pain, stomatitis, and pyrexia. Thrombocytopenia, neutropenia, and lymphopenia were the grade 3-4 laboratory abnormalities (≥15%).
Antiemetics are suggested prior to and during crizotinib therapy in individuals suffering from ALCL. Due to the risk of visual loss, the ophthalmologic assessments are suggested at baseline and serially thereafter, coupled with monthly evaluations of the visual symptoms and visual acuity. The suggested dose of crizotinib for systemic ALCL is 280 mg/m2 orally twice daily on the basis of body surface area.
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US FDA |
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[Last accessed on: 18 February, 2021] |
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Original title of the article |
FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma |
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