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Amgen Wins World-First Lumakras Approval, Faces Challenge Of COVID-Era Launch

US FDA Cleared KRAS G12C Inhibitor For Second-Line NSCLC

Executive Summary

Commercial EVP Murdo Gordon said launching sotorasib during the pandemic is a tougher challenge than encouraging doctors to screen lung cancer patients for KRAS G12C mutations and raising patient awareness.

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BMS Reports ‘Clinically Meaningful’ PFS Benefit In Topline Confirmatory Results For Krazati

Amgen’s Lumakras had hit a snag when the FDA questioned its confirmatory trial in the same indication, particularly the marginal PFS benefit and lack of OS benefit.

Amgen’s US Amjevita Sales Slow While Other Growth Drivers Deliver

Sales of the Humira biosimilar increased double digits globally year over year, but declined 63% in the US versus Q1 due to inventory stockpiling.

China’s KRAS Race: Homegrown Contenders Play Catch-Up

The sizzling race for China’s first approved KRAS inhibitor has seen Amgen/BeiGene’s Lumakras drop out and Mirati/Zai Lab’s Krazati lag in a confirmatory Phase III trial, while domestic fast-followers are in the meantime eyeing their first approval filings by the end of this year.

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