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# Pfizer’s Xalkori OK’d for Myofibroblastic Tumors
- URL: https://www.fdaweb.com/pfizers-xalkori-okd-for-myofibroblastic-tumors/
- Published: 2022-07-15T12:00:00.000Z
- Updated: 2026-09-14T17:52:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152294

FDA has approved a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). Approval was based on data from two single-arm, open-label trials that included 14 pediatric patients from trial ADVL0912 (NCT00939770) and seven adult patients from trial A8081013 (NCT01121588) with unresectable, recurrent, or refractory ALK-positive IMT, with both measuring objective response rate, according to an [agency release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-crizotinib-alk-positive-inflammatory-myofibroblastic-tumor?ref=fdaweb.com).

Of the 14 pediatric patients treated, a total of 12 patients (86%) experienced an objective response, which was assessed by an independent review committee, the agency says. For the seven adult patients, five patients had objective responses.