Filing of Xgeva (denosumab) in EU to treat hypercalcaemia of malignancy withdrawn after negative review by CHMP- Amgen

Following its earlier filing, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva (denosumab) to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer). Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.

The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients’ condition had responded to bisphosphonates, as the patients’ previous calcium levels were not available. Additionally, since patients were being treated with other hypercalcaemia treatments or had recently stopped treatment with bisphosphonates, it was not possible to determine the scale of the effect or whether the benefits observed in the study were due to Xgeva or were the effects of these other treatments. Therefore, at the time of the withdrawal, the CHMP was of the opinion that the results of the study were not sufficient and concluded that the medicine could not have been approved based on the data presented by the company.