Halaven(eribulin mesilate)

Halaven (eribulin mesilate) is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments. The marketing authorisation application was submitted on 30 March 2010, and a positive opinion from the CHMP was issued on 20 January 2011, leading to the granting of the marketing authorisation.

In efficacy studies, the median overall survival (OS) for Halaven was 399 days, compared to 324 days for the comparator arm, with an OS Hazard Ratio of 0.809 (95% CI: 0.660, 0.991) and an OS p-value of 0.041. An updated OS p-value was 0.014. Median progression-free survival (PFS) by independent review was 113 days for Halaven versus 68 days for the comparator, with a PFS HR of 0.865 (95% CI: 0.714, 1.048) and a p-value of 0.137. By investigator assessment, median PFS was 110 days for Halaven versus 66 days for the comparator, with a PFS HR of 0.757 (95% CI: 0.638, 0.900) and a p-value of 0.002.

Safety data from Phase 1 studies showed 13 subjects experienced at least one treatment-emergent adverse event (TEAE), with 12 subjects experiencing Grade 3 or higher TEAEs. Five subjects had at least one serious adverse event (SAE), and 2 fatal SAEs were reported. In Phase 2 studies, 27 subjects experienced at least one TEAE, 26 had treatment-related TEAEs, and 24 had treatment-related Grade 3 or higher TEAEs. Twelve subjects experienced at least one SAE, with 5 fatal SAEs reported. Four subjects discontinued due to TEAEs in Phase 2.