Both Halaven and Exjeva are new drugs very recently approved. I first consider whether the FDA indications are met.
HALAVEN 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).
Xgeva(denosumab) is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Since this member has bone mets, this criterion is met. 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.
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