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Saturday, Jul 2, 2022

Amgen Lung Cancer Drug Approved by FDA

The U.S. Food and Drug Administration gave accelerated approval to Lumakras, a drug from Amgen Inc. for adult patients with non-small cell lung cancer.“The FDA approval of Lumakras is a breakthrough moment for patients with KRAS G12C-mutated non-small cell lung cancer because there is now a targeted therapy for this common, but previously elusive, mutation,” Dr. David Reese, Amgen’s executive vice president of research and development, said in a statement.KRAS G12C mutations account for about 13 percent of mutations in non-small cell lung cancers. Mutant KRAS has built a reputation within the cancer research community as being undruggable due to its unorthodox shape as a protein.Lumakras’ path to U.S. regulatory approval took less than three years to complete. The FDA is requiring that a post-marketing trial be conducted to determine if a lower dose will yield a similar clinical effect.The drug is taken as oral tablets. According to NBC, the drug’s U.S. list price will be $17,900 per month.Shares of Thousand Oaks-based Amgen (AMGN) closed Thursday up 2 percent to $244.64 on the Nasdaq.

Antonio Pequeño IV
Antonio Pequeño IV
Antonio “Tony” Pequeño IV is a reporter covering health care, finance and law for the San Fernando Valley Business Journal. He specializes in reporting on some of the biggest names in the Valley’s biotechnology sector. In addition to his work with the Business Journal, Tony has reported with BuzzFeed News on the unsupervised use of Clearview AI, a controversial facial recognition technology. Tony, who also conducts freelance reporting, graduated from the USC’s Master of Science in Journalism program in 2021. He is in his fifth year as a journalist as of 2021.

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