More good news for Amgen as denosumab shows promise in cancer patients

US biotechnology major Amgen received a further boost over the weekend, when it announced positive results at the prestigious annual meeting of the American Society of Clinical Oncology (ASCO) being held in Chicago relating to its Prolia (denosumab) which less than a week earlier gained US Food and Drug Administration approval for the drug for the treatment of post-menopausal women with osteoporosis at high risk of fractures (The Pharma Letter June 2) and from the European Medicines Agency last month (TPL May28).

The news is a positive for the company, which is looking to replace revenues from two of its older drugs, Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), which have been subject to label changes to reflect problems with this erythropoiesis-stimulating agents (ESAs) class of compounds. In its first approved indication, Prolia has been forecast to generate peak sales of as much as $6 billion year, but added uses could lift that figure to $8.4 billion, some analysts have indicated.

Amgen presented results at the ASCO meeting from three denosumab studies in cancer patients. A Phase II study of metastatic patients previously treated with IV bisphosphonates found that denosumab normalized a key marker of bone resorption at a significantly greater rate than that seen with continuation of IV bisphosphonates, and also patients receiving denosumab experienced fewer skeletal-related events (SREs).