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Amgen gets FDA approval for potential billion-dollar drug

By   /   Friday, May 28th, 2021  /   Comments Off on Amgen gets FDA approval for potential billion-dollar drug

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Thousand Oaks-based Amgen won approval from the U.S. Food and Drug Administration on May 28 for its latest oral drug treatment, Lumakras, potentially adding another huge market for one of the largest biotech firms in the world.

According to the Wall Street Journal, Amgen will charge $17,900 a month for the drug and analyst think it could eventually generate $1 billion a year in sales. Amgen’s total revenue in 2020 was around $25 billion.

Lumakras is the culmination of more than 40 years of research, according to an Amgen spokesperson. It is meant to help people with a specific genetic mutation of lung cancer who have already tried other therapies.

That mutation is known as KRAS, and is commonly found in many cancers. According to a news release from the FDA, this is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. 

In a company news release, Amgen said Lumakras has demonstrated “a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced and metastatic non-small cell lung cancer harboring the KRASG12Cmutation.”

The drug is also being studied in multiple other solid tumors, Amgen said.

Lumakras was approved under the FDA’s accelerated approval pathway, under which the FDA approves drugs for serious conditions where there is unmet medical need and the drug is shown to have positive clinical benefits to patients.

Further study will still be used to verify and describe anticipated clinical benefits of Lumakras, according to the FDA.

In addition to receiving approval from the FDA, Amgen will be partnering with two companies — Guardant Health and QIAGEN — to develop blood- and tissue-based companion diagnostics for Lumakras, Amgen said. This companion diagnostic will help give more options and flexibility for KRAS G12C biomarker testing.

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