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Xalkori for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma, approved by FDA


The Food and Drug Administration ( FDA ) has approved Xalkori ( Crizotinib ) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma ( ALCL ) that is ALK-positive.
The safety and efficacy of Xalkori have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Efficacy was evaluated in Study ADVL0912, a multicenter, single-arm, open-label trial in patients 1 to less than or equal to 21 years of age that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after 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 Xalkori to undergo hematopoietic stem cell transplantation.

Efficacy was based on objective response rate ( ORR ) and duration of response as assessed by an independent review committee.
The ORR in the 26 patients was 88% ( 95% CI: 71, 96 ), with a complete remission rate of 81%. 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.

Ocular toxicity ( grade 1 or 2 visual disorders ) occurred in 65% of patients with ALCL, gastrointestinal toxicity occurred in 92%, and serious adverse reactions occurred in 35%, most often from neutropenia and infection.
The most common adverse reactions ( greater than or equal to 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 ( greater than or equal to 15% ) were neutropenia, lymphopenia, and thrombocytopenia.

The recommended Xalkori dosage for systemic anaplastic large cell lymphoma is 280 mg/m2 orally twice daily based on body surface area.
Antiemetics are recommended prior to and during treatment with Xalkori in patients with anaplastic large cell lymphoma.
Due to the risk of visual loss, ophthalmologic evaluations are recommended at baseline and serially thereafter, coupled with monthly assessments of visual acuity and visual symptoms.( Xagena )

Source: FDA, 2021

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