Leaders of the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recently gave a positive opinion about the anticancer agent Halaven.
Eisai Europe Ltd., the European regional headquarters of Eisai Co., designed Halaven (eribulin mesylate) to treat adults who have unresectable liposarcomas. These patients must prove that they received previous anthracycline therapies for metastatic or advances disease.
Thanks to the approval of treating metastatic breast cancer within Europe, Halaven has now gained a second achievement with the CHMP opinion. The review is based on a statistically significant extension from overall survival (OS).
Halaven, the first and only single agent that shows an OS, helped the patients involved in the Phase III trial. The patients had advanced, recurrent or metastatic soft tissue sarcoma.
The Phase III study compared the safety and effectiveness of Halaven with decarbazine. It involved 452 patients from the ages of 18 and above. All had locally advanced or recurrent and metastatic soft tissue sarcoma. Halaven showed a statistically significant extension in reaching the primary endpoint of the study’s OS compared to the decarbazine treatment.
Halaven’s most frequent treatment-emergent adverse events, which were more than or equal to approximately 25 percent, include fatigue, nausea, constipation, neutropenia, alopecia, abdominal pain, peripheral neuropathy and pyrexia.
