Eisai Inc. announced that FDA approved Halaven (eribulin mesylate) Injection (0.5 mg per mL). This marks the second indication for which Halaven has been approved by the FDA based on a statistically significant extension of survival.

Indication: HALAVEN is a microtubule inhibitor indicated for the treatment of patients with:

• Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

• Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Adverse reactions: The most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3-4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia.

Citation: FDA approves Eisai's Halaven (eribulin mesylate) injection for the treatment of patients with advanced liposarcoma. [news release]. Woodcliff Lake, NJ: Eisai Inc. January 29, 2016. http://eisai.mediaroom.com/2016-01-29-FDA-Approves-Eisais-Halaven-eribulin-mesylate-Injection-for-the-Treatment-of-Patients-with-Advanced-Liposarcoma. Accessed February 2, 2016.