AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Approval as the First Immunotherapy Regimen for Advanced Biliary Tract Cancer
Shots:
- The approval was based on the P-III (TOPAZ-1) trial evaluating Imfinzi + CT vs PBO + CT in 685 patients with unresectable advanced or metastatic BTC at 105 centers across 17 countries incl. in the US, EU, South America & multiple countries in Asia incl. South Korea, Thailand, Japan & China
- In an interim analysis, Imfinzi + CT showed a 20% reduction in risk of death, 25% vs 10% were still alive @2yrs. & the results were consistent across all prespecified subgroups regardless of PD-L1 expression or tumor location. The results were presented at ASCO GI Symposium 2022 and published in NEJM
- The therapy was well tolerated and did not increase the discontinuation rate due to AEs. The regulatory applications are also under review in the EU & multiple other countries
Ref: Businesswire | Image: AstraZeneca
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