Shots:

• The approval is based on P-III CROWN study assessing Lorbrena vs Xalkori (crizotinib) monthx in 296 people in a ratio (1:1) with prior untreated advanced ALK-positive NSCLC
• The P-III study resulted in a 72% reduction in risk of progression or death as assessed by BICR. The prespecified exploratory analysis showed IC-ORR was (82% vs 23%) as assessed by BICR; IC-DOR was 12 mos. or longer in (79% vs 0%) patients
• Lorbrena is a third-generation TKI and got accelerated approval in 2018. The FDA has now converted accelerated approval to full approval

 ­ Ref: Businesswire | Image: Geelong Medical and Health Group