Quick FDA approval gives Amgen drug competitive edge.

AMGEN Inc.'s first cancer drug, Vectibix, is on track to become the fastest commercial launch in the Thousand Oaks biotech giant's 25-year history.

The colorectal cancer treatment, which won U.S. Food and Drug Administration approval on Sept. 27 after regulators agreed to expedite the review process in mid-June, is likely to be on the shelves of major drug wholesalers before Oct. 10. In an industry where reviews can stretch more than a year, Vectibix is setting a blistering pace.

"This is a very big day for us strategically, because now we're in the tumor shrinking business," said Cynthia Schwalm, vice president and general manager of Amgen Oncology.

Several factors worked to give Amgen a fast start. In August 2005, the FDA gave the drug generically known as panitumumab a "fast track" designation usually reserved for drugs with the potential to address unmet medical needs. That enabled Amgen to start submitting clinical trial data and other information incrementally starting in December rather than wait until its entire submission package was complete.

Then in June, the company was given a date by which it could expect to hear yea or" nay from the government. Because Amgen staff were in close contact with FDA evaluators, they were confident enough that things were going well to give the go-ahead to start filling vials of Vectibix. All that was needed before boxing the drug was the approved language for the label, which arrived with last week's approval.

The drug will compete with ImClone Systems Inc.'s Erbitux, a similar antibody-based treatment that has been on the market for more than two years. Analysts are giving an edge to Vectibix, not only because of its therapeutic advantages and affordability compared to Erbitux, but Amgen's superior marketing muscle. The drug will be priced 20 percent lower than Erbitux and also will require injections every two weeks rather than weekly; that will price it at about $8,000 per month before insurance.