Shots:

• The EC’s approval is based on P-III ALTA-1L study assessing Alunbrig (180mg- qd with seven-day lead-in at 90mg- qd) vs crizotinib (250mg- bid) in 275 patients with ALK+ LA/m-NSCLC prior not treated with an ALK inhibitor
• The P-III ALTA-1L study results: Alunbrig showed superiority in anti-tumor activity- @2+yrs. follow up- reduction in risk of intracranial disease progression or death by 69% in patients with brain metastases- PFS (24.0 vs 11.0mos.) as assessed by BIRC and (29.4 vs 9.2mos.) as assessed by investigators
• Alunbrig is a potent and selective TKI inhibitor- designed to target and inhibit ALK fusion protein in NSCLC and has received the US FDA’s accelerated approval in Apr’2017. The EC’s approval follows CHMP’s positive opinion on Feb 27- 2020

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 Ref: PRNewswire | Image: Takeda