FDA Accepts sNDA for Soft Tissue Sarcoma Tx
Eisai announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the supplemental New Drug Application (sNDA) for eribulin mesylate being evaluated for patients with inoperable soft tissue sarcoma (leiomyosarcoma and liposarcoma) who have received prior chemotherapy for advanced or metastatic disease.
Eribulin is a microtubule dynamics inhibitor. Marketed under the brand name Halaven, it is currently indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic disease, and whose prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
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