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Amgen Lung Cancer Drug Sotorasib With Specific Mutation Gains FDA Approval

By John F. Heerdink, Jr.

Reportedly, Amgen Inc.’s (AMGN) drug sotorasib 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 gained approval from the U.S. Food and Drug Administration.

Sotorasib, to be sold under the brand name Lumakras, reduced tumors with the KRAS mutation in around 36% of patients in clinical trials. The drug will have a U.S. list price of $17,900 per month informed Amgen.

The medication is designed to target a gene mutation known as KRAS G12C occurring in about 13% of non-small cell lung cancers, the most common type of lung cancer. The KRAS mutation is also found in 1% to 3% of colorectal and other cancers. The company estimates that around 25,000 U.S. patients a year will be eligible for the drug.

FDA’s approval, which comes after more than two months is for a daily 960-milligram pill. The agency is also requiring Amgen to conduct a post-approval study to see if a lower dose is also effective. Amgen is looking for regulatory approval of the drug in Japan, Europe, and several other jurisdictions informed Amgen research chief, David Reese.

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(Read Original Story: FDA approves Amgen drug for lung cancer with specific mutation in Reuters)


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