US FDA turns down full approval of Amgen lung cancer drug Lumakras

The US FDA has rejected Amgen’s lung cancer drug Lumakras for full approval. The decision was based on concerns about the drug’s effectiveness and safety. This decision means that the drug can only be used under the FDA’s accelerated approval program, which allows for earlier access to promising drugs but requires additional studies to confirm their benefits. Amgen plans to work closely with the FDA to address their concerns and provide the necessary data for full approval in the future. This decision highlights the rigorous process that drugs must undergo for full approval in the US.

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