FDA approves Xalkori to treat anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors
The FDA has approved crizotinib (Xalkori) for the treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT) in adults and children over 1 year of age
Crizotinib is a selective tyrosine kinase inhibitor currently approved for the treatment of metastatic non-small cell lung cancer in patients whose tumors are positive for ALK or ROS1 as detected by an FDA-approved test, and for ALD-positive anaplastic large cell lymphoma. The latest approval comes after the application by drug manufacturer Pfizer was granted priority review. The approval is based on safety and efficacy findings from two multicenter, single-arm, open-label trials that included 14 children and 7 adults with unresectable, recurrent, or refractory ALK-positive IMT.
Pfizer has launched a pilot program that offered a warranty for the drug. The company said it will refund the cost of the medication if it doesn't work within the first 3 months of use.
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