Generic drugs online

Source: Thousand Oaks Acorn

Date: 2-Dec-2010

Author: Michelle Knight

An Amgen-created drug received the green light last month for use by cancer patients to reduce the risk of bone complications.

Denosumab, brand name XGEVA, was approved by the U.S. Food and Drug Administration on Nov. 18.

This is the second FDA approval for the generic denosumab in the past six months. In June, the FDA approved the protein to treat osteoporosis in post-menopausal women.

In most people who die of cancer, malignant cells have spread, or metastasized, from one part of the body to another, according to the American Cancer Society.

Dr. Alison Stopeck, breast cancer spetadalafilt and associate professor at Arizona Cancer Center in Tuscon, said bone is the most common place for cancer to spread.

Certain cancers, such as breast, prostate, kidney, lung and thyroid cancers, are more likely to spread to bone.

Cancer that has reached the bones-called bone metastasis- occurs worldwide in more than 1.5 million cancer patients, an Amgen report said. Three out of four cancer patients with bone metastasis will experience a debilitating bone complication that may require surgery or radiation.

With XGEVA, oncologists have an alternative to the traditional treatment of zoledronic acid, the generic name of Zometa, Stopeck said in a taped interview on Amgen's website.

"(XGEVA) provides patients with the security of knowing that they're getting a very effective and, in fact, more effective therapy than the previous standard of care," Stopeck said.

Lisa Rooney, spokesperson for the Thousand Oaks-based Amgen, said federal approval of XGEVA means cancer patients can be treated for bone degeneration by a simple injection every month. Zometa must be administered through an IV, usually every three to four weeks.

"We're elated with the FDA approval," Rooney said. "It's really meaningful for patients."

In three clinical trials, Amgen pitted Zometa against XGEVA therapy in some 5,700 patients with bone metastases brought on by more than 50 types of cancer. XGEVA reduced the risk of bone complications by 18 percent compared to Zometa, Rooney said.

Patients with other types of cancerous tumors experienced a similar reduction in the risk of bone problems, she said.

The FDA approval of XGEVA marks the first time in nearly 10 years that a new therapy is available to reduce bone complications in cancer patients, Rooney said.

"We're very proud of the work that so many people did here at Amgen to bring this drug to patients," she said.

Amgen has been studying XGEVA and its uses for the past 15 years. The FDA granted Amgen a priority review of the drug in June.

The six-month evaluation is approved only for drugs with the potential to advance treatment or provide adequate therapy where none exists.

But XGEVA has its disadvantages. The drug can cause ONJ, or osteonecrosis of the jaw, bone death due to poor blood supply. In Amgen's clinical trial, 2.2 percent of patients who received XGEVA developed ONJ. The majority of those patients had a history of dental issues, Rooney said.

The FDA reports osteonecrosis is also associated with Zometa therapy.

Also, hypocalcemia, lowerthan normal blood calcium, was more frequent in XGEVA patients than in patients using Zometa, according to an Amgen report.

The wholesale cost of XGEVA will be $1,650 a month. But Amgen provides help for privately insured cancer patients without requiring income eligibility.

Amgen is the largest private employer in the city of Thousand Oaks and in Ventura County. They are a large contributor to the city in three areas: sales tax, business and licensing fees and property tax.