Latest Japan Approvals Include Entyvio, Imfinzi, World-First Indication
Takeda’s global blockbuster GI drug Entyvio has been approved in Japan, although its local sales prospects appear limited, while two novel cancer drugs from AstraZeneca and a world-first indication have also been cleared by the health ministry.
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Following a priority review, Japan has approved AstraZeneca’s Tagrisso for the first-line treatment of inoperable or recurrent EGFR mutation-positive NSCLC, further strengthening the drug’s position in this setting.
New positive data with more convenient formulation set stage for increased Entyvio competitiveness in ulcerative colitis maintenance setting, while other early results bode well for Ninlaro in maintenance use in multiple myeloma.
Having already got off to a strong start on the US market on the back of stellar progression-free survival data, AstraZeneca’s immunotherapy Imfinzi has hit a second primary endpoint of the PACIFIC trial by improving overall survival in unresectable Stage III NSCLC patients, raising the bar even higher for future competition from rival PD-1/L1 inhibitors.