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FDA Expands Approval Of Pfizer's Lorbrena As Treatment For ALK-Positive Metastatic Lung Cancer

Pfizer Inc. (PFE) said that the U.S. Food and Drug Administration approved its supplemental New Drug Application or sNDA for Lorbrena or lorlatinib, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer or NSCLC. LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

The expanded approval of Lorbrena was based on the results from the pivotal Phase 3 CROWN trial, which showed a 72% reduction in risk of progression or death vs. XALKORI in a previously untreated patient population as assessed by blinded independent central review.

Lorbrena is a third-generation ALK inhibitor specifically designed to inhibit the most common tumor mutations that drive resistance to current medications and to address metastases in the brain, a frequent site for disease progression in ALK-positive NSCLC. Up to 40% of people with ALK-positive metastatic NSCLC present with brain metastases at initial diagnosis.

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