Shots:

• The approval was based on the P-III (CROWN) trial to evaluate Lorviqua as monothx. vs Xalkori as monothx. in a ratio (1:1) in 296 adult patients with ALK+ NSCLC prior not treated with an ALK inhibitor
• The results showed a 72% reduction in the risk of disease progression or death compared to Xalkori (crizotinib), ORR (76% vs 58%). patients experienced an intracranial response (71% had an intracranial complete response) 82% vs 23% in patients with measurable brain metastases & the safety profile was similar to previous studies
• Lorviqua was approved in the US under the brand name Lorbrena for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive

Ref: Pfizer | Image: Pfizer