Panel Calls for FDA Nod on Amgen Cancer Drug
A panel of experts recommended Thursday that the Food and Drug Administration approve Amgen Inc.’s new drug for advanced cancer patients receiving high-dose chemotherapy.
The agency’s final approval, which generally comes several months after a positive recommendation, would make the drug Stemgen available to patients undergoing stem cell transplants. In that procedure, stem cells are removed from the blood, stored during chemotherapy and then transfused back into patients to restore their ability to fight off infection.
Stem cells are the youngest cells in the blood. All blood cells actually begin as stem cells and then develop into white or red blood cells, or platelets.
Stemgen stimulates the production and release of the cells, reducing the number of sessions it takes to collect enough for a transplant. It makes it possible for some patients, who cannot produce enough of the cells on their own, to undergo the transplants.
“The benefits are not trivial; they are substantial,” said John Glaspy, one of the clinical investigators who performed the company trials for Amgen. “This represents an enabling technology which will help the field to move forward.”
The drug is not expected to have a sizable impact on the Thousand Oaks company’s earnings. The company estimates that 10,000 to 12,000 stem cell transplants are conducted each year. The procedure has been winning acceptance as a replacement for bone marrow transplants in certain patients with aggressive cancers.
Analysts see Stemgen as a useful companion to Amgen’s other product for cancer patients, Neupogen, which has annual sales in excess of $1 billion. Potential sales of the new drug could eventually reach $75 million a year, said Caroline L. Copithorne, a senior analyst for Prudential Securities.
“This is a $2.5-billion company,” she said. “Stemgen would add no more than 3% in sales.” And the stock market, she said, has for the most part anticipated its eventual approval.
The FDA advisory panel recommendation centered on which patients undergoing the transplants should be offered Stemgen. But as a practical matter, physicians are free to prescribe the medication to any patient they believe would benefit--regardless of the final label approved by the FDA.
In a recent interview, Amgen Chairman Gordon Binder described Stemgen as “quite small for us.” But he added, “If you were one of those patients getting a transplant, it would be a big drug for you.”
Amgen shares rose $1.06 to close at $76 on Nasdaq.
