AZ could withdraw urothelial carcinoma indication for Imfinzi in Brazil


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  • Argentina,Brazil,Cuba,Colombia,Chile,Puerto Rico ,Costa Rica,Panama,Peru,Paraguay,Uruguay,Venezuela,Ecuador ,Dominican Republic,Guyana,Bolivia ,Mexico,Haiti,Guatemala,Honduras,El Salvador,Belize,Nicaragua
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  • Pharma & Biotech

UK’s AstraZeneca (AZ) this week announced the withdrawal in the US market of an Imfinzi (durvalumab) indication in locally advanced or metastatic bladder cancer, suggesting that similar measures will be taken in other markets with similar approvals. The decision was made after the drug last year failed to meet its primary endpoints in the DANUBE Phase III study, on whose results a 2017 accelerated approval was contingent. Indications for non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) were not dependent on the confirmatory trial.

According to GBI analysis, Imfinzi does have an indication approval for urothelial carcinoma in Brazil, but is indicated only for lung cancers in Argentina, Chile, and Colombia. It is unclear if the drug is approved for bladder cancer in the markets of Costa Rica, Dominican Republic, or Mexico, where it is also registered.

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