Takeda’s Alunbrig (brigatinib) Receives EC’s Approval as a 1L Treatment for ALK+ Advanced Non-Small Cell Lung Cancer

Takeda’s Alunbrig (brigatinib) Receives EC’s Approval as a 1L Treatment for ALK+ Advanced Non-Small Cell Lung Cancer

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

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Takeda