TGA pri­or­ity re­view regis­tra­tion

Pharmacy Daily - - News -

THE Ther­a­peu­tic Goods Ad­min­is­tra­tion has an­nounced that Alec­tinib (Ale­censa) is the first medicine to be reg­is­tered on the Aus­tralian Reg­is­ter of Ther­a­peu­tic Goods via the new Pri­or­ity Re­view Path­way which be­came ef­fec­tive on 01 Jul 2017.

The medicine was also the first to be granted a pri­or­ity re­view de­ter­mi­na­tion by the TGA.

The ap­proved ap­pli­ca­tion ex­tends the drug’s pre­vi­ously reg­is­tered in­di­ca­tions to in­clude the treat­ment of pa­tients with anaplas­tic lym­phoma ki­nase (ALK)-pos­i­tive, lo­cally ad­vanced or metastatic non­s­mall-cell lung cancer.

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