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.
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.
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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