Amgen seeks regulatory approval for bone metastasis treatment

THOUSAND OAKS, Calif. Amgen has submitted a regulatory approval application to the Food and Drug Administration for a drug to prevent the spread of tumors to the bones in cancer patients, the biotech company said.

The Thousand Oaks, Calif.-based drug maker announced the submission of a biologics license application to the FDA for denosumab. The regulatory submission was based on data from nearly 6,900 patients in 18 clinical studies, including three phase 3 studies comparing the drug with Novartis’ Zometa (zoledronic acid).

The spread of tumors to bones, also known as bone metastasis, is a serious concern for many patients with advanced cancer. When it happens, the cancer cells can weaken and destroy the bone around a tumor, raising the risk of fractures, spinal cord compression or the need for radiation therapy or bone surgery. Bone metastases occur in more than 1.5 million cancer patients worldwide, most often in those with prostate, lung and breast cancers, exerting an economic burden of $12.6 billion a year on cancer patients in the United States alone. The drug targets a biological pathway believed to be central in cancer-related bone destruction, regardless of cancer type.

“We believe that denosumab will offer substantial benefit to cancer patients suffering from bony metastases,” Amgen EVP research and development Roger Perlmutter said. “Denosumab, administered monthly as a 120-mg dose subcutaneously, demonstrated consistently similar or greater efficacy in clinical trials when compared to zoledronic acid, offering the potential to improve on the current standard of care. One potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary.”