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Japan Recommends Approval Of Brukinza, Balversa

Brogidirsen, Iclepertin To Get Sakigake Status

 
• By Lisa Takagi

Along with several new positive approval recommendations, Japan's proceeding to grant Sakigake designation to two drugs including a DMD gene therapy discovered through public collaboration. Meanwhile, the PMDA has opened a new full-time office in the US.

(Shutterstock)

Japan‘s Ministry of Health, Labour and Welfare (MHLW) has recommended for approval several new drugs including Johnson & Johnson’s FGFR kinase inhibitor Balversa (erdafitinib) and BeiGene’s BTK inhibitor Brukinsa (zanubrutinib).

Balversa was filed for Japanese approval in November 2023 for adult patients with unresectable or metastatic, malignant urothelial carcinoma harbouring susceptible FGFR3

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