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Fda Approves Durvalumab For Non Muscle Invasive Bladder Cancer

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Durvalumab for Bladder Cancer: Survival & NNT Explained

A phase II trial presented at the American Society of Clinical Oncology annual meeting in Chicago found that 85% of muscle-invasive bladder cancer patients who received immunotherapy drug durvalumab alongside chemotherapy and radiotherapy remained cancer-free after one year, without surgical bladder removal.

A phase II trial presented at the American Society of Clinical Oncology annual meeting in Chicago found that 85% of muscle-invasive bladder cancer patients who received immunotherapy drug durvalumab alongside chemotherapy and radiotherapy remained cancer-free after one year, without surgical bladder removal.

The trial, led by Prof. Nick James at the Institute of Cancer Research, London, and funded by AstraZeneca and the University of Birmingham, enrolled 54 patients. In prior trials, chemoradiation without immunotherapy kept cancer from returning in 60% of patients after one year.

The trial, led by Prof. Nick James at the Institute of Cancer Research, London, and funded by AstraZeneca and the University of Birmingham, enrolled 54 patients. In prior trials, chemoradiation without immunotherapy kept cancer from returning in 60% of patients after one year.

Durvalumab is a PD-L1 inhibitor that blocks a protein cancer cells use to evade the immune system. The drug was previously approved by the National Institute for Health and Care Excellence for NHS use in muscle-invasive bladder cancer alongside chemotherapy and surgery.

Durvalumab is a PD-L1 inhibitor that blocks a protein cancer cells use to evade the immune system. The drug was previously approved by the National Institute for Health and Care Excellence for NHS use in muscle-invasive bladder cancer alongside chemotherapy and surgery.

On May 28, 2026, the FDA approved durvalumab in combination with BCG for adult patients with BCG-naive, high-risk non-muscle invasive bladder cancer, marking the first new therapy approved in over 30 years for this patient group, according to trial co-investigator Neal Shore, MD.

On May 28, 2026, the FDA approved durvalumab in combination with BCG for adult patients with BCG-naive, high-risk non-muscle invasive bladder cancer, marking the first new therapy approved in over 30 years for this patient group, according to trial co-investigator Neal Shore, MD.

The FDA approval was based on the phase 3 POTOMAC trial, which enrolled 1,018 patients and showed durvalumab plus BCG reduced the risk of disease recurrence or death by 32% compared to BCG alone. The 24-month disease-free survival rate was 86.5% in the durvalumab arm versus 81.6% with BCG alone.

The FDA approval was based on the phase 3 POTOMAC trial, which enrolled 1,018 patients and showed durvalumab plus BCG reduced the risk of disease recurrence or death by 32% compared to BCG alone. The 24-month disease-free survival rate was 86.5% in the durvalumab arm versus 81.6% with BCG alone.

For patients who cannot avoid surgery, the FDA-approved drug Inlexzo offers an alternative for those who have not responded to BCG treatment, achieving an 83% complete response rate in that group. A patient assistance program is available through manufacturer Johnson & Johnson.

For patients who cannot avoid surgery, the FDA-approved drug Inlexzo offers an alternative for those who have not responded to BCG treatment, achieving an 83% complete response rate in that group. A patient assistance program is available through manufacturer Johnson & Johnson.

Immunotherapy Keeps 85% Bladder Cancer Patients Surgery-Free

DurvalumabImmunotherapy Keeps 85% Bladder Cancer Patients Surgery-Free

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Immunotherapy Keeps 85% Bladder Cancer Patients Surgery-Free

DurvalumabImmunotherapy Keeps 85% Bladder Cancer Patients Surgery-Free

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