FDA Grants Priority Review to Eribulin for Soft-Tissue Sarcoma

October 16, 2015

The US Food and Drug Administration has granted a Priority Review designation to eribulin for the treatment of inoperable soft-tissue sarcoma.

The US Food and Drug Administration (FDA) granted a Priority Review designation to eribulin for the treatment of inoperable soft-tissue sarcoma. The application is specifically for patients who have received prior chemotherapy for advanced or metastatic disease.

“Advanced soft-tissue sarcoma is very difficult to treat, so we are excited to be one step closer to potentially bringing an additional treatment option to patients in need,” said Kenichi Nomoto, PhD, president of Eisai’s Oncology Product Creation Unit, in a press release.

The new drug application submitted to the FDA for eribulin is specifically for patients with advanced leiomyosarcoma and liposarcoma. Eribulin is a microtubule dynamics inhibitor, the first agent in what is known as the halichondrin class. It is currently approved for patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens-specifically an anthracycline and a taxane in either the adjuvant or metastatic setting.

The drug is still being investigated in sarcoma patients. Results of one phase II study were published in 2011 in Lancet Oncology, and showed promising outcomes. Of 38 leiomyosarcoma patients who received eribulin, 31.6% were progression free at 12 weeks. Also, 46.9% of adipocytic sarcoma patients, 21.1% of synovial sarcoma patients, and 19.2% of other types of sarcoma patients were progression free at 12 weeks.

The most common adverse events in that phase II study included neutropenia, leucopenia, anemia, and fatigue.

A phase III study is currently ongoing testing eribulin’s efficacy in advanced soft-tissue sarcoma patients who received at least two prior standard treatment regimens. The study is expected to include about 450 patients, and has an estimated completion data of February 2016.

The Priority Review granted to eribulin means the FDA has set a goal to take action on the application within 6 months. The standard review period is 10 months.