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Lorbrena FDA Approval History

Last updated by Judith Stewart, BPharm on March 10, 2021.

FDA Approved: Yes (First approved November 2, 2018)
Brand name: Lorbrena
Generic name: lorlatinib
Dosage form: Tablets
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer

Lorbrena (lorlatinib) is an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) positive as detected by an FDA-approved test.

Development timeline for Lorbrena

Mar  3, 2021Approval U.S. FDA Expands Approval of Pfizer’s Lorbrena as First-Line Treatment for ALK-Positive Metastatic Lung Cancer
Nov  2, 2018Approval FDA Approves Lorbrena (lorlatinib) for Previously-Treated ALK-Positive Metastatic Non-Small Cell Lung Cancer
Feb 12, 2018U.S., EU and Japan Health Authorities Accept Regulatory Submissions For Review Of Pfizer’s Third-generation ALK Inhibitor Lorlatinib
Oct 16, 2017Pfizer Presents Full Results from Phase 2 Study of Next-Generation Investigational ALK-Inhibitor Lorlatinib in ALK-Positive and ROS1-Positive Advanced Non-Small Cell Lung Cancer

Further information

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