Amgen has made a second submission to regulators in the USA for denosumab, this time for bone loss in cancer patients.

Specifically, the US biotech major has filed Biologics License Application to the US Food and Drug Administration for denosumab, a RANK ligand inhibitor, for the reduction of skeletal related events in cancer sufferers. The submission is based on nearly 6,900 patients across 18 clinical studies, including 5,700 people with advanced cancer in the three Phase III head-to-head trials versus Novartis’ Zometa (zoledronic acid).

Head of research at Amgen, Roger Perlmutter said that denosumab, administered monthly as a 120mg dose subcutaneously, “demonstrated consistently similar or greater efficacy in clinical trials when compared to zolendronic acid, offering the potential to improve on the current standard of care”. Amgen intends to submit marketing applications shortly in the European Union, Switzerland, Canada and Australia, and also in Japan, with licensing partner Daiichi-Sankyo.

Bone metastases occur in more than 1.5 million patients with cancer worldwide, Amgen noted, and are most commonly associated with cancers of the prostate, lung, and breast. Incidence rates are as high as 75% of patients with metastatic disease, the company added, and “the economic burden” of US patients with bone metastases is estimated to be $12.6 billion annually.

The BLA represents the second submission for denosumab filed with the FDA as the drug is currently being reviewed (under the tradename Prolia) for the treatment and prevention of postmenopausal osteoporosis. In October last year, the agency issued a complete response letter for Prolia, asking for further information on the design of Amgen's previously submitted post-marketing surveillance programme and a request for a new clinical plan to support approval.

Amgen responded and the FDA has set a Prescription Drug User Fee Act date of July 25. Denosumab is vital to the company’s future success and if approved for both of the aforementioned indications, analysts believe it will comfortably reach blockbuster status.