Pfizer announced that the U.S. Food and Drug Administration (FDA) had accepted the supplemental new drug application for Xalkori (crizotinib); the new approval is for treating pediatric patients with relapsed or refractory systemic anaplastic lymphoma kinase-positive anaplastic large cell lymphoma.
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Anaplastic large cell lymphoma is a rare non-Hodgkin lymphoma; the cancer is of two types: ALK-positive or ALK-negative. There is a high unmet need in pediatric patients with ALK-positive anaplastic large cell lymphoma, though the survival rate was as much as 80%. Pediatric patients experience a difference in the response for medicines and therapies are usually associated with prolonged risk of side effects.
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The approval is based on the Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 was conducted along with Study ADVL0912; the study was intended to determine the safe and tolerable dose in children. Study A8081013 was designed to evaluate the efficacy of Xalkori in adults and pediatrics; the trial was conducted in patients with ALK-positive malignancies other NSCLC, which included patients with relapsed or refractory ALCL.
Xalkori is a tyrosine kinase inhibitor, approved for treating ALK-positive or ROS1-positive NSCLC.
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