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US FDA approves Amgen's colorectal cancer therapy
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US FDA approves Amgen's colorectal cancer therapy
Jan 16, 2025 4:22 PM

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.

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