FDA Panel Gives Green Light to New Amgen Biotech Drug

A U.S. Food and Drug Administration advisory panel recommended Friday that Amgen Inc.’s newest biotechnology drug be approved for use in cancer patients.

The drug, called granulocyte colony-stimulating factor, spurs production of white blood cells that help chemotherapy patients fight off infections. Analysts think it will become a blockbuster product, eventually a $200-million- to $450-million-a-year seller for Amgen, based in Thousand Oaks.

Final FDA approval for G-CSF is now virtually certain, said Jim McCamant, editor of Medical Technology Stock Letter in Berkeley. He expects the drug to be on the market within a few months.

The news ignited Amgen stock. It surged $2.75 Friday to a record $59.25 per share.

But Amgen’s new drug will have competition. On Thursday, Immunex, a Seattle-based biotechnology concern, also received a favorable review from an FDA panel on its new white blood cell product called GM-CSF.

However Immunex’s drug is expected to be approved to treat bone marrow transplant patients, while Amgen’s drug would be approved for cancer patients undergoing chemotherapy.

“The cancer market is much larger,” McCamant said. Insurance companies, he said, tend to reimburse for new drugs only if they are used according to FDA recommendations, so McCamant initially expects Amgen to dominate the white blood cell drug market.

The drug will be Amgen’s second biotechnology product. Its first, a gene-spliced protein called erythropoietin or EPO, produces red blood cells that treats chronic anemia in patients with kidney disease. EPO sales are running at an annualized rate of about $300 million with profits from the drug coming at the rate of nearly $50 million a year.