Jan 16 (Reuters) - The U.S. Food and Drug Administration
approved Amgen's ( AMGN ) combination therapy on Thursday to
treat colorectal cancer in patients with a specific gene
mutation.
Amgen's ( AMGN ) Lumakras in combination with Vectibix was approved
to treat adult patients whose cancer has spread to other parts
of the body despite receiving chemotherapy, the health regulator
said.
The FDA also approved Netherlands-based Qiagen's ( QGEN )
companion diagnostic device to identify patients eligible for
the combination treatment.
Lumakras is an oral drug designed to target a mutated form
of the KRAS gene, which occurs in 3% to 5% of colorectal
cancers, while Vectibix is a monoclonal antibody that targets a
mutated form of the EGFR gene, known for causing rapid tumor
cell growth.
The approval was based on a late-stage study showing the
combination treatment extended progression-free survival to 5.6
months, compared with two months with standard care, the agency
said.
Last year, the FDA approved Bristol Myers Squibb's ( BMY )
Krazati to treat colorectal cancer in patients with KRAS
mutation.
Colorectal cancer, the third most common cancer globally, is
also the second leading cause of cancer-related deaths,
according to the World Health Organization.