FDA approves Amgen drug for lung cancer with specific mutation

imageStock Markets51 minutes ago (May 28, 2021 01:00PM ET)

(C) Reuters.

By Deena Beasley

(Reuters) – The U.S. Food and Drug Administration on Friday approved an Amgen Inc (NASDAQ:AMGN) 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.

The medication is designed to target a gene mutation known as KRAS G12C that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common type of lung cancer.

Amgen estimates that around 25,000 U.S. patients a year will be eligible for the drug. The KRAS mutation is also found in 1% to 3% of colorectal and other cancers.

The approval, which comes more than two months before the FDA’s target decision date, 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 could be effective.

Cancer drugs are typically developed at the highest tolerable dose, but some oncologists have urged the FDA to do more to require drugmakers to optimize dosing https://

“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 part of a growing trend of precision medicines that target gene mutations driving cancer regardless of which organ the disease originated.

Reese said Amgen is studying Lumakras in combination with other drugs as an initial treatment for NSCLC patients who have the KRAS mutation, as well as for other types of cancer.

Amgen is also seeking regulatory approval of the drug in Europe, Japan and several other jurisdictions, he said.

FDA approves Amgen drug for lung cancer with specific mutation

Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.