Vinflunine: drug safety evaluation of this novel synthetic vinca alkaloid.
ABSTRACT INTRODUCTION: Vinca alkaloid agents have been widely used in several different types of malignancies. However, cancer cells, ultimately, develop resistance to these agents. Therefore, the development of new agents with improved efficacy is warranted. Recently, a new synthetic vinca alkaloid, vinflunine, was developed through the addition of two fluor molecules by superacidic chemistry. AREAS COVERED: The authors describe the development of the new vinca alkaloid vinflunine from preclinical studies to the late-stage clinical trials, highlighting the most important clinical and safety data of vinflunine. In vitro and in vivo studies have shown a superior efficacy of vinflunine over other vinca alkaloids and with an improved safety profile. Early clinical trials have demonstrated a significant activity of vinflunine against different malignancies. Phase III trials showed that vinflunine increases survival in patients with advanced transitional cell carcinoma of the urothelium (TCCU) tract treated in the second-line and is as effective as docetaxel in second-line NSCLC. EXPERT OPINION: Vinflunine is currently approved in Europe for the treatment of second-line TCCU and is currently being developed in other malignancies. It has been shown to have predictable and manageable adverse effects, such as neutropenia, anemia, constipation and fatigue.
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ABSTRACT: In the past few years, innumerable novel anti-cancer agents have been developed. Some of them have successfully entered into clinical practice while some of them have failed for different reasons. Although, nowadays, cancer treatment still relies heavily on conventional chemotherapy and surgery, with increasing evidence of novel biologic agents which demonstrate its higher anti-cancer activity and fewer side effects, more and more efforts have been spent on development of different types of novel agents. Vinflunine, a novel fluorinated vinca alkaloid, carries mitotic-arresting and tubulin-interacting properties and was just approved for treating transitional cell carcinoma of the urothelial tract (TCCU) in Europe. It, however, took quite a long time to get an approval. Needless to say, TCCU, similar to other types of cancer, is a very complex and heterogeneous disease and therefore, a single drug can hardly eradicate a cancer. Translational research, a new scientific research method, creates a link between clinical and laboratory studies. The link helps us to investigate the change in tumor environment in response to treatment, select patients who are more responsive to a particular treatment and predict prognosis of a group of patients with similar tumor characteristics. It can not only improve the success of a treatment, but also maximize the potential of novel anti-cancer agents.Expert Opinion on Drug Safety 09/2011; 11 Suppl 1:S5-8. · 2.62 Impact Factor