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
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)