Denosumab for the prevention and treatment of skeletal related events (SRE) from bone metastases

Denosumab (Prolia), under development by Amgen, is the first fully human monoclonal antibody (MAb) in late stage clinical development that specifically targets RANK Ligand (RANKL), an essential regulator of osteoclasts, the cells that break down bone. Among other indications, Prolia is being investigated for the treatment and prevention of bone loss resulting from hormone ablation in patients with breast and prostate cancer, as well as for its potential to delay bone metastases and inhibit and treat bone destruction in patients with multiple myeloma and across many stages of cancer. In direct evaluation against zoledronic acid (Zometa; Novartis), the current standard of treatment of bone loss associated with cancer metastasized to the bone, denosumab was superior to Zometa in preventing skeletal related events (SRE) and delayed worsening of bone pain in a phase III clinical trial of 2,046 patients with advanced breast cancer. In addition, denosumab also presented some potential tolerability advantages for many patients, including a lower incidence of renal toxicity and acute phase reactions, combined with the convenience of a monthly SC injection. Similarly, in another phase III clinical trial, denosumab was non-inferior to Zometa in the treatment of bone metastases in 1,776 patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma.

Noxafil against invasive fungal infections

In pharmacoeconomic studies published in the American Journal of Health System Pharmacy http://www.ajhp.org/cgi/content/abstract/65/23/2237 and in Value in Health http://www3.interscience.wiley.com/journal/121636980/abstract, comparing Noxafil (posaconazole) Oral Suspension, with fluconazole or itraconazole, prophylaxis with Noxafil in certain invasive fungal infections in severely immunocompromised patients reduced overall costs. Such infections represent a significant cause of morbidity and mortality in these patients. In fact, patients undergoing hematopoietic stem cell transplants (HSCT) who develop such an infection have a high mortality rate varying between 50%-90% (Bow EJ, etal, Cancer 2002;94:3230-46).