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# Pfizer Gains Breakthrough Status for Expanded Xalkori Uses
- URL: https://www.fdaweb.com/pfizer-gains-breakthrough-status-for-expanded-xalkori-uses/
- Published: 2018-05-29T12:00:00.000Z
- Updated: 2026-09-15T00:08:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141546

FDA has granted Pfizer a Breakthrough Therapy designation for Xalkori (crizotinib) for treating patients with metastatic non-small cell lung cancer (NSCLC) who have MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The agency also granted a Breakthrough Therapy designation for the therapy and its use in patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase (ALK)-positive. Xalkori is currently approved for treating patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.