Amgen set back in bid to upgrade Lumakras approval

28 December 2023

Californian biotech Amgen (Nasdaq: AMGN) has announced that the US Food and Drug Administration has rejected its bid for full approval of Lumakras (sotorasib).

The product has been sold following its approval under the Accelerated Approval scheme, in May 2021, which provides for a company to market a product pending further confirmatory data.

That decision made Lumakras the first KRASG12C inhibitor to reach the market in the USA.

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