AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: The US FDA has approved AZ's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction & maintenance therapy for the treatment of adults with BCG-naïve, high-risk NMIBC; regulatory review is ongoing in the EU & Japan Approval was based on the P-III (POTOMAC) trial of 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi…

ByRidhi RastogiMay 29, 2026

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AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

Shots: Trial enrolled 695 MIBC pts undergoing radical cystectomy who were ineligible for or declined cisplatin & randomized them to Arm 1 [neoadj. 3 Imfinzi + EV cycles with Imjudo (2 cycles), then adj. Imfinzi (9 cycles) + 1 Imjudo cycle], Arm 2 [neoadj. Imfinzi + EV (3 cycles), then adj. Imfinzi (9 cycles)], or…

ByRidhi RastogiMay 14, 2026

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AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Shots: AstraZeneca has reported P-III (POTOMAC) trial findings assessing Imfinzi in 1018 high-risk, BCG-naïve NMIBC pts post-TURBT, randomized to Imfinzi + BCG induction & maintenance, Imfinzi + BCG induction-only, or SoC BCG therapy Imfinzi + BCG induction & maintenance therapy showed improved disease-free survival (DFS; 1EP) vs SoC BCG, while Imfinzi + BCG induction-only did…

ByRidhi RastogiMay 12, 2025

AstraZeneca Receives the US FDA Approval for Imfinzi Regimen to Treat High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

AstraZeneca Reports the P-III (VOLGA) Trial Data on Imfinzi + Enfortumab Vedotin (EV) for Muscle-Invasive Bladder Cancer

AstraZeneca Reports P-III (POTOMAC) Trial Findings of Imfinzi Regimen for High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

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