Amgen Nabs EU Approval for Lumykras for Treating KRAS-Mutated Lung Cancer

Amgen Nabs EU Approval for Lumykras for Treating KRAS-Mutated Lung Cancer

Amgen’s Lumykras (sotorasib) — branded as Lumakras in the U.S. — has won conditional marketing approval in Europe for treating adults with KRAS G12C-mutated nonsmall-cell lung cancer (NSCLC) who have tried at least one prior line of therapy.

The authorization was supported by results from a 126-person phase 2 study in which more than 37 percent of patients responded to treatment with Lumykras, with a mediation duration of response lasting just over 11 months. A confirmatory, global phase 3 study enrolling 345 patients is currently underway.

In May 2021, Sotorasib received FDA accelerated approval for the same indication, becoming the first KRAS G12 inhibitor to gain regulatory clearance.

The potential blockbuster drug is being investigated for treating a variety of solid tumors.

January 11, 2022

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