Amgen Inc. has received a breakthrough therapy designation from the Food and Drug Administration for an investigational drug to treat advanced, metastatic non-small-cell lung cancer.

The coveted designation expedites development and regulatory review of medicines that meet an unmet need. Positive Phase 2 data led to the designation, Amgen said. Patients in this trial saw their cancer progress despite prior treatment with chemotherapy and in some cases immunotherapy as well.

The drug, called sotorasib, targets the most common mutation in this type of lung cancer, which is found in approximately 25,000 U.S. patients every year.


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