FRANKFURT May 23 U.S. health regulators on Friday approved Qiagen NV's gene-testing kit to identify those colorectal cancer patients most likely to benefit from Amgen Inc's drug, Vectibix, Qiagen said.
In addition, the Food and Drug Administration expanded the approval of Vectibix to allow its use as a first-line, or initial, treatment for colon cancer in combination with the widely used FOLFOX chemotherapy regimen, Amgen said.
The expanded Vectibix approval is for patients who have a non-mutated, or wild type, KRAS gene after clinical trials demonstrated that those patients were most likely to be helped by the drug.
The FDA approval for the genetic test marks the third U.S. approval for a Qiagen companion diagnostic for use in combination with a specific drug, a key growth market for the German company.
Both approvals could pave the way for increased use of Vectibix, which has been largely a disappointment for Amgen. It means the drug can be used earlier in the disease and would be accompanied by a standardized diagnostic to help doctors pinpoint patients that would best respond to the medicine.
Amgen had $389 million in sales from Vectibix last year, $126 million of which came from U.S. sales.
Close to 40 percent of colorectal cancer patients have tumours with mutated forms of the KRAS gene, which make them poor candidates for Vectibix. The rest have the non-mutated, or wild, forms and stand a better chance of benefiting from the drug, which was approved in the United States in 2006. (Reporting by Ludwig Burger in Frankfurt and Bill Berkrot in New York. Editing by Andre Grenon)