After a debate regarding the benefits and disadvantages of Amgen Inc’ Drug Xgeva brought on the attention of regulators, the Food and Drug Administration has decided to reject its use down the line.
U.S. health regulators have been advised to reconsider their position regarding Amgen Inc’s drug Xgeva, after it has been confirmed that the drug’s benefits do not outweigh the risk it carries to develop a much urgent condition.
Panel member Maha Hussain, professor of medicine in the hematology and oncology division at the University of Michigan, stated: “If you ask a patient, ‘Do you want to delay your disease by five minutes, but get significant toxicities?’ I think that would give them pause”.
A patient that talked in front of the panel said: “There isn’t a treatment that a man with prostate cancer gets that doesn’t have devastating effects on his masculinity and his quality of life”. Based on that, he thinks that “the men who would be candidates for this treatment would be standing up and cheering another option for them”.
Xgeva is a drug that has been originally approved in the use of delaying fractures and other bone injuries in patients with cancers that already spread to the bones. Xgeva’s maker, Amgen is working to gain approval for the drug’s use in the limitation of prostate cancer in a trial with male patients who have not responded to other therapies.
Although the drug was proved to delay the spread of cancer to the bone by about four months, some of the 1,432 prostate cancer patients involved in the trial developed osteonecrosis of the jaw. The findings showed about one in 15 men who took Xgeva experienced damage of the jawbone.
Michael Severino, Amgen’s vice president of research and development, said yesterday that the company is confident Xgeva does provide a clinically meaningful benefit since it does delay the spread of cancer to the bone, a development which causes significant issues, such as intense pain and incontinence.
Xgeva is also sold for the treatment of osteoporosis, but it is administered at a lower dose and not as often as in the treatment of other bone cancer complications. Xgeva for osteoporosis is sold under the brand name Prolia, which targets the protein called RANK Ligand which regulates cells called osteoclasts that damage the bone.