Amgen's Lumakras approved by the FDA

May 31, 2021
Amgen's Lumakras approved by the FDA

One of the world's leading biotechnology companies revealed that the Food and Drug Administration cleared its key lung cancer treatment

Amgen's Lumakras, a medicine designed to treat a non-small cell lung cancer with a specific mutation gene known as KRAS, was cleared by the FDA on Friday.

According to data from Amgen, Lumakras shrank tumours having the KRAS mutation in about 36% of patients in clinical trials. "The LUMAKRAS development program was a race against cancer for Amgen's scientists and clinical-trial investigators who together have now successfully delivered this new medicine to patients in less than three years -- from the first patient dosed to U.S. regulatory approval," stated the company's Executive Vice President of Research David Reese.

FDA's decision came after last month’s proposal that the once-daily treatment be compared with a lower daily dose of the drug. Amgen agreed, and the results are expected in late 2022.

In March, Amgen announced the purchase of Five Prime Therapeutics for $1.9 billion to expand its cancer-drug pipeline.

Lumakras will be listed at $17,900 per month in the U.S.

Following the news, Amgen closed the trading session 1.2% up at $238.23 per share.

Sources: finance.yahoo.com, thestreet.com

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