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There is no separate FDA or EMA approval specifically for the combination “cisplatin + gemcitabine” for non‑small‑cell lung cancer (NSCLC)”; instead, this regimen is used as an off‑label, guideline‑recommended platinum‑based doublet in advanced or locally advanced NSCLC. In practice, cisplatin + gemcitabine is widely used as a standard first‑line chemotherapy doublet for advanced NSCLC (especially squamous histology) based on phase III trials showing efficacy comparable to other platinum‑containing regimens, even though the label wording focuses on the agents individually.
see also:
[Cisplatin + Gemcitabine & Non-Small-Cell-Lung-Cancer (NSCLC)](brain://Bs_fnfVUpUyV8BSW65k2kA/Cispl…