Durvalumab Plus BCG Earns FDA Nod for Bladder Cancer
The FDA has approved durvalumab in combination with BCG for high-risk non-muscle-invasive bladder cancer. This decision is based on the results of the POTOMAC study, which showed improved disease-free survival for patients receiving the combination treatment. The recommended dosage for durvalumab is 1500 mg every four weeks, alongside BCG induction and maintenance.
- ▪Durvalumab has been approved by the FDA for use with BCG in treating high-risk non-muscle-invasive bladder cancer.
- ▪The approval is based on the POTOMAC study involving 1018 patients.
- ▪Patients receiving durvalumab plus BCG showed significantly improved disease-free survival compared to those receiving BCG alone.
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The FDA has approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NIMBC).Approval was based on findings from the randomized, open-label POTOMAC study of 1018 patients with high-risk NIMBC who had undergone transurethral bladder tumor resection, according to the FDA approval notice. Patients who were randomized to durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance experienced significantly improved disease-free survival (DFS) vs those randomized to BCG induction and maintenance alone (hazard ratio, 0.68).
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Excerpt limited to ~120 words for fair-use compliance. The full article is at Medscape.
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