FDA approves Eisai’s Halaven in liposarcoma
Posted: 29 January 2016 | | No comments yet
Halaven is the first and only single agent to demonstrate an overall survival benefit in a Phase III trial in patients with leiomyosarcoma or liposarcoma…
The US Food and Drug Administration (FDA) has approved Eisai’s Halaven (eribulin mesylate) for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic).
Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced or recurrent and metastatic soft tissue sarcoma (leiomyosarcoma or liposarcoma).
This approval was based on the results from a Phase III study (Study 309) comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and 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 (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven median OS: 15.6 months vs dacarbazine median OS: 8.4 months). Additionally, in the study’s secondary endpoint of progression-free survival (PFS), patients treated with Halaven experienced an improvement in PFS over dacarbazine (Halaven median PFS: 2.9 months vs dacarbazine median PFS: 1.7 months).
“A clinically meaningful drug”
Commenting on the approval, Richard Pazdur, M.D., director of the Office of Haematology and Oncology Products in the FDA’s Centre for Drug Evaluation and Research, said: “Halaven is the first drug approved for patients with liposarcoma that has demonstrated an improvement in survival time. The clinical trial data the FDA reviewed indicates that Halaven increased overall survival by approximately seven months, offering patients a clinically meaningful drug.”
Applications seeking approval of Halaven for use in the treatment of soft tissue sarcoma have been submitted in Europe and Japan. Meanwhile, the agent has been designated as an orphan drug for the treatment of soft tissue sarcoma in the United States and Japan.