Food and Drug Administration approves Amgen’s Lumakras for KRAS Mutation

The U.S. Food and Drug Administration (FDA) gave nod to Amgen’s Lumakras under rapid approval as a cure for patients detected with non-small cell lung cancer with a particular gene mutation whose disease have worsen with time.

It is the only FDA-approved treatment for this particular type of lung cancer.

Lumakras (sotorasib) was accepted to treat adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as fixed by an FDA-approved test, who have been given at least one prior-systemic therapy.

That test, the Guardant Health-developed Guardant360 CDx test, was also given green light by the FDA along with Lumakras.

Amgen’s Lumakras will go on to be recognised in clinical studies to show its efficacy and safety.

Amgen’s executive vice president of Research and Development, David Reese, called the approval of Lumakras a “breakthrough moment” for medicine and patients with this specific type of lung cancer. He added that the patients would gain the benefit from a particular therapy for a mutation that has been difficult to track down by researchers for decades.