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The FDA has approved the CRCdx® RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer, according to an announcement from EntroGen.
The U.S. Food and Drug Administration on Friday approved an Amgen Inc drug for non-small cell lung cancer with a specific mutation in a gene known as KRAS in patients whose disease has worsened after treatment with chemotherapy or other medicines. The drug, sotorasib, which will be sold under the brand name Lumakras, shrank tumors with the KRAS mutation in around 36% of patients in clinical trials. Amgen said the drug will have U.S. list price of $17,900 per month.