Updated on 9 May 2016
Japan's pharma major Eisai Co Ltd announced that its European regional headquarters Eisai Europe Ltd has received from the European Commission approval for anticancer agent Halaven (eribulin mesylate) for the treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Halaven is said to be the first and only single agent to demonstrate a statistically significant overall survival (OS) benefit in a phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma).
Following approval for use in the treatment of metastatic breast cancer, this marks the second indication for which Halaven has received approval based on an extension of OS.
The approval was based on the results of a phase III study comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study's primary endpoint of OS over the comparator treatment dacarbazine.
The press release explained that Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores.