Clinical Amgen's KRAS drug gets early FDA approval for lung...

Amgen’s KRAS drug gets early FDA approval for lung cancer with specific mutation


On Friday, the United States FDA (Food and Drug Administration) has authorized a medication of Amgen Biopharmaceutical in patients with NSCLC ( Non-small cell lung cancer), who have a particular mutation in the KRAS gene, and whose condition has become worse despite being treated with chemotherapy and other medications.

In clinical studies, the drug named sotorasib, which will be marketed as Lumakras has shown a significant reduction in tumor size with KRAS gene mutation in roughly 36% of cancer patients. The drug will cost around $17,900 per month in the United States, according to Amgen.

This drug is specially developed to target the KRAS G12C mutated genes, which takes place in approximately 13% of NSCLC, the most prevalent type of lung cancer.

Amgen believes that the therapy will be accessible to roughly 25,000 individuals in the United States each year. This KRAS mutation can also be detected in 1%-3% of colorectal cancer and other malignancies.

FDA has approved a 960mg OD ( once a day) tablet, over two months before the scheduled date. Amgen is also required to do a post-approval analysis to assess the effectiveness of medication in low doses.

Although cancer medications are designed at a greater acceptable dosage, several oncologists have encouraged the FDA to go a little further in compelling the manufacturers to improve the dosage of the drug.

“Our sense is this is going to become more common in oncology,” Amgen research chief David Reese told Reuters in a phone interview.

Lumakras is among the rising trend of targeted medications that target cancer-causing gene abnormalities, irrespective of the origin of the disease.

Amgen is evaluating Lumakras in combination with other medications as first-line therapy for Non-small cell lung cancer patients with KRAS gene mutation, and many other cancer types, according to Reese.

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