Shots:

• The US FDA has granted PR to Takeda’s sNDA for the expanded use of Alunbrig (brigatinib) as 1L treatment for patients with ALK+ metastatic NSCLC detected by FDA-approved test
• The sNDA is based on P-III ALTA-1L study assessing the Alunbrig (180mg qd with 7days preparatory phase to 90mg qd) vs crizotinib (bid) in 275 patients with LA/m-NSCLC- prior not treated with ALK inhibitor. The study resulted in meeting its 1EPs i.e- superiority in PFS
• Alunbrig is a news generation ITK inhibitor targeting genetic alterations in ALK with its anticipated PDUFA date as Jun 23- 2020

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 Ref: Business wire  | Image: Takeda