Amgen has received a boost with the news that regulators in the USA have granted a priority review to the company’s recently-approved denosumab, this time for the reduction of skeletal related events in advanced cancer patients.
Denosumab, under the brandname Prolia, was approved by the US Food and Drug Administration in May for postmenopausal women with osteoporosis who are at high risk for fractures. Now the agency has given priority review designation to the subcutaneous RANK ligand inhibitor for the treatment of bone metastases to reduce SREs in patients with cancer.
The application, which was also submitted in May, includes data from 18 clinical studies on nearly 6,900 patients, including some 5,700 with advanced cancer in three Phase III trials comparing denosumab head-to-head with Novartis’ Zometa/Reclast (zoledronic acid).
The priority review for this new indication means that the FDA is expected to make a decision within six months. This translates to a prescription drug user fee act (PDUFA) action date of November 18.
Amgen’s head of R&D, Roger Perlmutter, said that the priority review designation “underscores the potential for denosumab to provide a meaningful advance over the current standard of care for patients with metastatic bone disease”. The company noted that bone metastases occur in more than 1.5 million patients with cancer worldwide 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, Amgen added, and “the economic burden” of US patients with bone metastases is estimated to be $12.6 billion annually. The firm has submitted marketing applications shortly in the European Union, Switzerland, Canada and Australia, and a filing is planned soon in Japan, with licensing partner Daiichi-Sankyo.
