Classic cytotoxic drugs: a narrow path for regulatory approval
Mené sur 405 patientes atteintes d'un cancer du sein métastatique réfractaire aux anthracyclines et aux taxanes, cet essai de phase III évalue l'efficacité, du point de vue de la survie sans progression, et la toxicité de l'ajout d'utidélone à la capécitabine
Several classic cytotoxic drugs have shown encouraging activity in the treatment of metastatic breast cancer.1–3 However, only a few have received an overwhelming welcome from regulatory authorities and succeeded in obtaining widespread regulatory approval for routine use. For example eribulin was approved for treatment of metastatic breast cancer in several countries including Japan, USA, and Europe, based on data that showed longer overall survival in patients treated with eribulin compared with patients treated with physician's choice of treatment.
The Lancet Oncology , commentaire, 2016