Amgen Gets Favorable FDA Designation

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.“Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib,” the biotech giant said in a statement. The inhibitor is being studied across four continents with more than 600 patients involved.Amgen plans to submit a new drug application to the FDA by the end of the year, according to a statement from Dr. David Reese, executive vice president of research and development at Amgen.The announcement was made Tuesday. Shares of Amgen (AMGN) closed up 91 cents, or less than one percent, to $229.85 on the Nasdaq on Wednesday, a day when the overall Nasdaq was down nearly 2 percent. On Thursday, Amgen’s stock closed at $228.16, down $1.69, or less than one percent.