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Denosumab (Xgeva) edges towards EU approval for MM-related SREs

Mar 6, 2018

Amgen’s monoclonal antibody densoumab (xgeva) is edging closer towards approval in the European Union (EU) for the treatment of Multiple Myeloma (MM) patients with Skeletal Related Events (SREs). On 23 February 2018, the Committee for Medicinal Products for Human Use(CHMP) recommended an expansion of the current indication for denosumab, having reviewed recent phase III trial data to assess denosumab in comparison with the currently used drug zoledronic acid (ZA) – see previous MM Hub article.

The study enrolled 1718 Newly Diagnosed (ND) MM patients and indicated a superior progression-free survival (PFS) with denosumab (46.1 months) compared to ZA (35.4 months). Importantly, denosumab led to less renal toxicity (10% vs17%) in comparison to ZA, which can be nephrotoxic if taken long-term. This, therefore, offers a safer long-term option to MM patients with SREs at risk of developing renal complications, or those already presenting with severe renal damage.

  1. http://www.onclive.com/web-exclusives/denosumab-approaches-european-approval-for-myeloma