Amgen speeds up commercialization of its KRAS drug
By Eo, Yun-Ho | translator Alice Kang
21.06.02 17:17:53
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Prepares for marketing authorization in Korea immediately after U.S. approval¡¦ was designated an orphan drug in March
First new drug in 40 years¡¦ Sanofi¡¤MSD also conducting clinical trials on KRAS drugs
Industry sources have said that Amgen Korea has submitted an application for the marketing authorization of the first-ever KRAS-targeted anticancer therapy, ¡®Lumakras (sotorasib),' on the 28th to the Korean Ministry of Food and Drug Safety (MFDS) immediately after receiving accelerated approval from the U.S. FDA.
Amgen's actions seem to be an attempt to solidify Lumakras's position as a first-in-class treatment. As the drug had already received orphan drug designation from the Korean Ministry of Food and Drug Safety in March, the approval process is expected to go smoothly unless there is a special
Eo, Yun-Ho(unkindfish@dailypharm.com)
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