Xgeva regulatory update
The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Xgeva denosumab from Amgen to prevent skeletal-related events (SREs) in patients with bone metastases from breast cancer; and in patients with bone metastases from solid tumors other than breast and prostate cancer for whom zoledronic acid would be indicated. The recommendation, which is contingent on Amgen providing Xgeva at an undisclosed discount under a patient access scheme, does not recommend Xgeva to prevent SREs in patients with bone metastases from hormone-refractory prostate cancer (HRPC). Final guidance is expected next month.
In April, NICE issued a preliminary appraisal recommending the use of Xgeva to prevent SREs in patients with bone metastases from hormone-refractory prostate cancer (HRPC), from breast cancer and from solid tumors other than breast and prostate cancer for whom zoledronic acid would be indicated (see BioCentury, April 2). In June, NICE said it no longer thought Xgeva was cost-effective to prevent SREs in patients with bone metastases from HRPC, but said it still thought Xgeva was cost-effective for the other indications (see BioCentury, June 18). ...