A phase III trial of Halaven (eribulin) in patients with soft tissue sarcoma demonstrated a statistically significant extension in overall survival over the comparator treatment dacarbazine, the primary endpoint of the study. No other systemic treatment for locally advanced or metastatic soft tissue sarcoma has been reported to extend overall survival in a phase III study, according to Halaven’s sponsor, Eisai.
A group of melanoma experts, joined by three advocacy groups focused on melanoma, has engaged FDA in a public discussion of the challenges of developing new drugs in the refractory setting and the role crossover can play in such trials.
