Belimumab efficacy is 'mild' but market potential still great†: anticipating us approval of the first lupus drug since 1957.

Speaking for the inThought Expert Discussion Series in February, Dr George Tsokos mirrored the opinion of many lupus thought leaders: Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) belimumab (Benlysta®) was likely to be approved by the US FDA and, despite modest efficacy, will be used by a large proportion of lupus patients. Dr Tsokos praised HGS and GSK's clinical trial program for belimumab, noting that huge trials and unique trial endpoints were needed to demonstrate the drug's efficacy, allowing it to succeed where so many other lupus drugs have failed. Still, belimumab's trial design may not become standard in future lupus trials - questions about identification of appropriate lupus patients with active disease, trial endpoints, and subgrouping lupus patients remain.

Trials define anti-tumor effects of anti-resorptive agents: denosumab ahead of zoledronate 2 to 1.

New data presented at the 2010 meeting of the American Society of Hematology (ASH), at the 33rd San Antonio Breast Cancer Symposium (SABCS), and released by Amgen are beginning to define the anti-tumor effects of Amgen's denosumab (Xgeva™) and Novartis's zoledronate (Zometa®) in multiple myeloma, breast cancer, and prostate cancer. Just prior to the ASH meeting, Amgen received approval of denosumab for oncology indications. The antibody against RANK ligand, already approved as Prolia® for osteoporosis, will need to demonstrate advantages over its primary competitor zoledronate, a bisphosphonate.