Pfizer Inc. 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 -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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