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The Cisplatin + Gemcitabine doublet is an established, on‑label regimen for advanced/metastatic Bladder cancer under both FDA and EMA, although the approval is expressed via the gemcitabine label (in combination with cisplatin) rather than as a fixed co‑packaged product (1, 2)
The combination Cisplatin + Gemcitabine is a standard therapy for metastatic Bladder cancer (4)
The randomized clinical phase III trial, identified as NCT00942331 (CALGB 90601), demonstrated that with a median follow-up period of 76.3 months for patients wh…