(Reuters) – The U.S. Food and Drug Administration approved Amgen’s combination therapy on Thursday to treat colorectal cancer in patients with a specific gene mutation.
Amgen’s 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 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 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.
(Reporting by Mariam Sunny in Bengaluru; Editing by Sherry Jacob-Phillips)
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