Both Halaven and Exjeva are new drugs that were recently approved.
HALAVEN( eribubilin) is 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.
This was based on an open-label, randomized, multicenter trial of 762 patients with metastatic breast cancer who received at least two chemotherapeutic regimens for the treatment of metastatic disease and experienced disease progression within 6 months of their last chemotherapeutic regimen, EMBRACE study. A statistically significant improvement in overall survival was observed in patients randomized to the Halaven arm compared to the control. An updated, unplanned survival analysis, conducted when 77% of events had been observed, was consistent with the primary analysis. In patients randomized to Halaven, the objective response rate by the RECIST criteria was 11% (95% CI: 8.6%, 14.3%) and the median response duration was 4.2 months (95% CI: 3.8, 5.0 months). The difference between overall survival in the 2 treatment groups was statistically significant; median overall survival was 13.1 months with eribulin and 10.6 months with TPC (hazard ratio, 0.81; P = .041).
This was significant but not very pronounced. The magnitude of the improvement is similar to what has been reported for docetaxel vs mitomycin plus vinblastine (31%), and for capecitabine plus docetaxel vs docetaxel alone (26%). It does not mean that Havalen is better than all other chemo choices, which remains for subsequent studies to determine, only that it is somewhat better than “any single-agent treatment (chemotherapy, hormonal or biological) or radiotherapy or symptomatic therapy alone”. Many physicians chose to use vinorelbine, gemcitabine, or capecitabine in the control arm; none chose supportive care and none used combinations.There was a prior phase II study that included patient pre-treated with anthracyclines, taxanes or capecitibine.
Xgeva(denosumab) is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. In the pivotal study, Denosumab was superior to zoledronic acid in delaying or preventing SREs in patients with breast cancer metastatic to bone and was generally well tolerated. With the convenience of a subcutaneous injection and no requirement for renal monitoring, denosumab represents a potential treatment option for patients with bone metastases. It is not approved for myeloma but there are studies supporting it for that diagnosis.
Halaven, Prescribing Information: http://www.eisai.com/pdf_files/Halaven_PI.pdf, 2013
35th Annual San Antonio Breast Cancer Symposium (SABCS): Abstract S6-6. Presented December 7, 2012
nccn, Breast Cancer 2013
Alison T. Stopeck, et al, Denosumab Compared With Zoledronic Acid for the Treatment of Bone Metastases in Patients With Advanced Breast Cancer: A Randomized, Double-Blind Study JCO November 8, 2010 JCO.2010.29.7101
Monica N. Fornier Denosumab: Second Chapter in Controlling Bone Metastases or a New Book? JCO Dec 10, 2010:5127-5131
David H. Henry, Luis Costa, Francois Goldwasser, Vera Hirsh, Vania Hungria, Jana Prausova, Giorgio Vittorio Scagliotti, Harm Sleeboom, Andrew Spencer, Saroj Vadhan-Raj, Roger von Moos, Wolfgang Willenbacher, Penella J. Woll, Jianming Wang, Qi Jiang, Susie Jun, Roger Dansey and Howard Yeh, Randomized, Double-Blind Study of Denosumab Versus Zoledronic Acid in the Treatment of Bone Metastases in Patients With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma. JCO March 20, 2011 vol. 29 no. 9 1125-1132
Xgeva, Prescribing Information
Read the Layperson version here.