(RTTNews) - Pfizer Inc. (PFE) announced Monday that the positive results from Phase 3 CROWN study of LORBRENA (lorlatinib) in people with previously untreated advanced anaplastic lymphoma kinase or ALK-positive non-small cell lung cancer or NSCLC.
The trial met its primary endpoint by demonstrating significantly improved progression-free survival, as compared to XALKORI (crizotinib).
The results were reviewed by an independent Data Monitoring Committee at a planned interim analysis. The safety profile for lorlatinib and crizotinib were consistent with what has been previously seen in clinical trials.
The company will submit the results from CROWN for presentation at an upcoming medical congress.
Based on the positive outcome of the CROWN trial, the company said it intends to share the results with the U.S. Food and Drug Administration and other health authorities to support conversion to full approval and to seek approval for an indication that includes previously untreated ALK-positive metastatic NSCLC.
In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.
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