Denosumab approved for bone cancer use
pharmafile | November 19, 2010 | News story | Sales and Marketing | Amgen, Cancer, Prolia, Xgeva, denosumab
Amgen’s denosumab has been approved in the US to prevent serious bone problems in patients with solid tumour cancers.
Denosumab is already approved to treat osteoporosis under the brand name Prolia, but will be know as Xgeva in the oncology arena.
The approval is a key one for Amgen, as analysts forecast the drug could generate peak annual sales of over $1billion from the oncology use alone.
The spread of cancer to the bones – bone metastases – are a serious problem for patients with advanced cancer, and can lead to fractures and compression of the spinal cord. Patients may then require major surgery and radiation to prevent or manage bone complications. Amgen’s drug helps prevent these sometimes crippling complications, called skeletal-related events (SREs).
The drug was approved by the FDA under its six-month priority review system, and the speedy review reflects Xgeva (denosumab) being a major advance in the therapy area.
Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
“Today’s approval of Xgeva illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine,” said Kevin Sharer, chairman and chief executive of Amgen. “A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating. We are pleased to offer this new advance to patients and their healthcare providers.”
“As many as three out of four patients with advanced prostate, lung, and breast cancer will experience spread to their bones. Despite the availability of current treatments, a significant proportion of these patients still experience bone complications or are not candidates for existing treatment,” said David H. Henry, M.D., clinical professor of medicine, and vice chair, Department of Medicine, Pennsylvania Hospital, University of Pennsylvania Healthcare System.
Dr Henry said he expected to see the drug become a ‘mainstay of cancer care,’ but its high cost may be a barrier to uptake in the US and elsewhere.
A month’s treatment with Xgeva will cost $1,650 in the US, or approximately $20,000 a year. This is almost double the cost of Novartis’ Zometa, its main competitor.
Xgeva was approved based on three head-to-head phase III trials with Zometa. The drug was tested in patients with a range of different tumour types. Xgeva was found to be superior to Zometa in preventing SREs in breast cancer, prostate cancer and bone metastases, but produced similar results in other solid tumours and multiple myeloma patients.
The new drug also has some administration advantages over its rival. Xgeva is given every four weeks as a 120 mg subcutaneous injection, while Zometa is administered every four weeks via a 15-minute intravenous infusion, and must be adjusted for kidney function.
Overall rates of adverse events and serious adverse events were generally similar between XGEVA and Zometa. Osteonecrosis of the jaw (ONJ) was infrequent, with no statistically significant difference between treatment arms, however hypocalcemia – low levels of calcium – was more frequent in the Xgeva arm. Doctors are advised to monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary.
Despite its advantages in treating SREs, Xgeva cannot claim better overall survival and progression-free survival in patients on Zometa based on the three trials.
Xgeva is awaiting approval in the European Union, Australia, Canada and Switzerland. Amgen is co-marketing the drug in Japan with Daiichi-Sankyo.
Andrew McConaghie
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