|FDA panel votes against Xgeva; Nervous GlaxoSmithKline Pulls Cash Out of Eurozone|
|By Staff and Wire Reports|
|Wednesday, 08 February 2012 20:31|
A panel of cancer experts voted against a new use for Amgen Inc.'s (NASDAQ:AMGN) Xgeva in prostate cancer saying the drug's ability to slow the spread of the disease did not translate into meaningful benefits for patients.
The FDA's cancer drug panel voted 12-1 that the benefits of the drug did not outweigh its risks, which included bone disease in about 6 percent of patients. The FDA is not required to follow the group's advice, though it often does.
Xgeva is already approved to prevent fractures in cancerous bones, and for osteoporosis, in a different formulation called Prolia.
Amgen Inc. has asked the FDA to approve the injectable drug as a preventive measure for men with recurring prostate cancer that is at high risk of spreading to the bone. At the public meeting Wednesday, Amgen scientists pointed to results of a company study showing patients taking Xgeva experienced a four-month delay in the spread of cancer to the bones around the prostate.
Panelists termed this a "statistical benefit," but not one that resulted in increased survival or higher quality of life for patients.
"The effect of the studied compound is quite weak with no effect on survival or the overall course of the disease in general," said Dr. Ronald Richardson of the Mayo Clinic. All of the panel's physicians voted against the company's application. The lone patient representative on the panel voted in favor.
Many cancer drugs approved by the FDA do not actually extend survival, but instead slow the growth of tumors or their spread to other parts of the body. In recent years, cancer experts have debated the meaningfulness of these measures. Panel chair Dr. Wyndham Wilson acknowledged that delaying the disease's spread to the bone could be meaningful, but suggested the drug would have to do so for more than four months.
"If it was one year we probably wouldn't even be here today, no one is denying that, but the magnitude here is quite low," said Wilson, a research chief at the National Cancer Institute.
Panelists also raised concerns about exposing patients to the drug's side effects, including osteonecrosis of the jaw, in which the bone dies because of poor blood supply.
Doctors use a variety of treatments and interventions to treat prostate cancer, depending on the speed of the cancer's growth and the patient's age, among other factors. Patients with fast-growing prostate tumors often receive hormone therapy to stop production of testosterone, which fuels cancer growth.
All of the men in Amgen's study had tumors that did not respond well to hormone therapy, but had not yet spread beyond the prostate. While there are multiple drugs for both early and late-stage prostate cancer, Amgen argued "there is a gap in the treatment plan for those patients" enrolled in its study.
GlaxoSmithKline Plc, (NYSE:GSK) Britain's biggest drugmaker, has been sweeping cash on a daily basis from euro-zone banks in a bid to protect itself from potential problems in the single currency bloc, its chief executive said.
"We don't leave any cash in most European countries," Andrew Witty told reporters after presenting fourth-quarter results on Tuesday.
"We sweep all of our cash raised during the day out of the local banks and send it to banks here in the UK which we think are robust and secure."
The system has been in place since early last year and involves the movement of "tens of millions of pounds" in cash each day, he added.
In recent months, many business leaders have started to contemplate the possibility of a break-up of the euro, even though this is still viewed as unlikely. For non-financial firms, a key focus is on safeguarding cash and ensuring cash deposits are in the safest possible banks.
The pharmaceuticals industry has already been hit hard by the crisis in the euro zone, which has seen a number of southern European governments slashing prices for medicines. Drug manufacturers also face a growing problem of unpaid bills.
In the case of Greece, drugmakers have been forced to accept government bonds instead of cash for some outstanding debts. Those bonds were either sold immediately at a discount or are still sitting on the companies' books at even lower value today.
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