Shots:

• The approval is based on P-I/II (B7461001) study assessing Lorbrena (100mg- qd) in 215 patients with ALK-positive metastatic NSCLC- who were treated with one or more ALK TKIs
• The P-I/II (B7461001) study resulted in ORR (48%) with intracranial response rate 60% with serious AEs 32% out of 295 patients
• Lorbrena (lorlatinib) is a third-generation anaplastic lymphoma kinase (ALK) TKI indicated for patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC and is currently approved in Japan for ALK fusion gene-positive unresectable advanced and/or recurrent NSCLC with resistance or intolerance to ALK TKI

Ref: Pfizer | Image: Pharma News