Vinorelbine (navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France), a novel semisynthetic vinca alkaloid, is the first drug approved by the Food and Drug Administration in over 20 years for the first-line treatment of ambulatory patients with unresectable advanced non-small cell lung cancer (NSCLS). In a multicenter, randomized US trial, single-agent vinorelbine produced response rates of 12%, compared with prior single-center studies demonstrating a response rate of 30%. Furthermore, in the US trial, median survival for patients receiving vinorelbine was 30 weeks, with a 1-year survival rate of 25%, compared with 22 weeks for 5-fluorouracil and leucovorin, with a 1-year survival rate of 16%. This impact on survival was confirmed in a European multicenter randomized trial. In this study, vinorelbine as a single agent demonstrated a median survival of 31 weeks, with a 1-year survival rate of 30%. Single-agent vinorelbine was comparable to the combination of vindesine/cisplatin, which had a median survival of 32 weeks and a 1-year survival rate of 27%. By contrast, the combination of vinorelbine/cisplatin produced a medial survival of 40 weeks and a 1-year survival rate of 35%. The major dose-limiting toxic effect of vinorelbine is granulocytopenia. Vinorelbine has demonstrated a survival advantage in patients with advanced NSCLC in two controlled clinical trials and has been associated with a favorable safety profile associated with a low incidence of hospitalization. These findings would suggest that vinorelbine alone or in combination with cisplatin may be a cost-effective treatment for appropriate patients with advanced NSCLC.