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New Indication Sought for Eribulin (Halaven) as Treatment for Soft-Tissue Sarcoma
Eisai Co., Ltd. has submitted an application to the FDA seeking an additional indication for its anticancer agent eribulin mesylate (Halaven) as a treatment for soft-tissue sarcoma.
According to Eisai, eribulin is the only single-agent systemic therapy to demonstrate an improvement in overall survival (OS) in patients previously treated for soft-tissue sarcoma in a randomized controlled trial.
Conducted primarily in the U.S. and Europe, Study 309 was an open-label, randomized, phase III trial comparing the efficacy and safety of eribulin with that of dacarbazine in 452 patients (18 years of age or older) with locally advanced or recurrent and metastatic soft-tissue sarcoma (one of two subtypes: leiomyosarcoma or adipocytic sarcoma). All of the patients had experienced disease progression after standard therapies (including an anthracycline and at least one other additional regimen). The patients received either eribulin (1.4 mg/m2 administered intravenously on day 1 and day 8) or dacarbazine (850 to 1,200 mg/m2 administered intravenously on day 1) every 21 days until disease progression occurred.
Eribulin demonstrated a statistically significant extension in OS (the study’s primary endpoint) compared with dacarbazine (median OS: 13.5 months vs. 11.5 months, respectively; P = 0.017). In addition, while there was a numerical difference in the progression-free rate at 12 weeks between eribulin and dacarbazine (33% vs. 29%, respectively), this finding was not statistically significant. Median progression-free survival was 2.6 months in both treatment arms.
The most common treatment-emergent adverse events observed in eribulin-treated patients included fatigue or asthenia, neutropenia, nausea, alopecia, and peripheral neuropathy.
The findings were presented at the 51st annual meeting of the American Society of Clinical Oncology (ASCO) in June 2015.
Soft-tissue sarcoma is a collective term for a group of malignant tumors that occur throughout the soft tissue (i.e., fat, muscle, nerves, fibrous tissues, and blood vessels) in the body. Approximately 12,000 people in the U.S. are diagnosed with soft-tissue sarcoma each year.
Eribulin mesylate is a halichondrin-class microtubule dynamics inhibitor. It was first approved for the treatment of metastatic breast cancer in the U.S. in 2010. It is now designated as an “orphan drug” for the treatment of soft-tissue sarcoma.
Source: PipelineReview; July 30, 2015.