Denosumab FDA approved for the prevention of MM-related SREs

On 5 January 2018 Amgen announced that the US Food and Drug Administration (FDA) had approved the use of denosumab to treat skeletal-related events (SREs) in Multiple Myeloma (MM) patients. Denosumab is a fully humanized antibody that binds to and neutralizes RANK ligand (RANK-L) secreted by osteoblasts and is involved in bone resorption.

This decision was based on data from the phase III 482 study, in which 1178 Newly Diagnosed (ND) MM patients were recruited and treated with either denosumab or the bisphosphonate zoledronic acid (ZA). The data from this study was presented at the 2017 ASCO Annual Meeting, and reported by the MM Hub. Of note, the progression free survival (PFS) was 10.7 months higher in the denosumab group and confers strong benefits for patients with renal impairment as, unlike ZA, it is not processed by the kidney.

This will be welcome news for Amgen after a long wait for the decision; the application to expand the indication of denosumab was submitted on 4 April 2017 – see previous MM Hub article. Denosumab is a key player in Amgen’s portfolio and is already indicated for the treatment of SREs in a number of other solid tumors. This will now provide long-awaited benefits for MM patients in the US; an application was submitted to the European Medicines Agency (EMA) at the same time, so it will be hoped that the EMA will also choose to follow suit.