The US Food and Drug Administration (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.
An objective response was observed in 12 of 14 pediatric patients and 5 of 7 adult patients in those trials. Adverse reactions occurring in 35% or more pediatric patients included vomiting, nausea, diarrhea, abdominal pain, rash, vision disorder, upper respiratory tract infection, cough, pyrexia, musculoskeletal pain, fatigue, edema, constipation, and headache. In adults, the most common adverse reactions were vision disorders, nausea, and edema.
Crizotinib recently made headlines when Pfizer launched a pilot program that offered a warranty for the drug. As reported by Medscape Medical News, the company said it will refund the cost of the medication if it doesn’t work within the first 3 months of use.
“Through this pilot program, Pfizer will offer a warranty to patients and health plans ― Medicare Part D, commercial and those who pay cash ― who are prescribed Xalkori for an FDA-approved indication,” a company spokesperson said at the time.
For the latest indication, the recommended crizotinib dose in adults is 250 mg orally twice daily until disease progression or unacceptable toxicity, and in pediatric patients is 280 mg/m2 orally twice daily based on body surface area, until disease progression or unacceptable toxicity.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.