Amgen gets a no from the FDA on extended use of Xgeva

The FDA told Amgen ($AMGN) no to an expanded use of its cancer treatment Xgeva, one of the company's most important drugs, saying the company could try again with more data.

The drug is already approved to delay fractures and stave off tumor growth in patients who have developed bone metastases. Amgen was recommending that it be used to treat advanced prostate cancer patients to prevent or delay the disease's spread to the bone. The data: Patients who took Xgeva saw bone tumors crop up an average of 4.2 months later than those on placebo did. Overall survival time didn't differ.

But the ruling was generally expected after the advisory panel voted 12-1 in February against the new use. Its rationale was why not wait until the tumors develop to treat with Xgeva, since about 1 in 15 patients in the trial developed osteonecrosis of the jaw? "This isn't a question of whether this drug works," the panel chair, Wyndham Wilson, said at the time. "It's a question of when is the most effective time to give it."

Xgeva is seen as one of those drugs that could join the billion-dollar-a-year club. Sales in the first quarter of 2012 were $153 million, up 14% from last quarter, Reuters reports. Amgen said there are about 50,000 men in the advanced stages of prostate cancer at any given time who could have benefited from the use.

Sean Harper, Amgen's executive VP of R&D, says the company "will work with FDA to determine any next steps."

- read the Reuters story