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# FDA Accepts Pfizer sNDA for Xalkori Indication
- URL: https://www.fdaweb.com/fda-accepts-pfizer-snda-for-xalkori-indication/
- Published: 2020-09-23T12:00:00.000Z
- Updated: 2026-09-14T16:29:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147717

FDA has accepted and granted priority review for a Pfizer sNDA for Xalkori (crizotinib) for treating pediatric patients with relapsed or refractory systemic anaplastic large-cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK) positive. The agency granted breakthrough designation for the ALK-positive ALCL indication 5/2018\. If the sNDA is approved, it would be the first biomarker-driven therapy for this type of pediatric lymphoma, a Pfizer [statement](https://www.pfizer.com/news/press-release/press-release-detail/fda-accepts-supplemental-new-drug-application-pfizers?ref=fdaweb.com) says. The PDUFA goal date for an FDA decision is 1/2021.

Pfizer says Xalkori is a tyrosine kinase inhibitor that is indicated for treating patients with metastatic non-small cell lung cancer whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.