FDA OKs 1st targeted drug for common lung cancer mutation

U.S. regulators have approved the first medicine for patients with the most common type of lung cancer whose tumors have a genetic mutation long considered untreatable with drugs

FAIRLESS HILLS, PA. -- U.S. regulators have approved the first medicine for patients with the most common type of lung cancer whose tumors have a genetic mutation long considered untreatable with drugs. The Food and Drug Administration on Friday said it has approved Amgen’s drug Lumakras to treat non-small cell lung cancer with the mutation in patients who have worsened after initial treatment with at least one other drug. Each year, about 13,000 U.S. patients are diagnosed with this cancer and mutation. This is the first targeted therapy for tumors with a so-called KRAS mutation, the FDA noted. This type of mutation occurs in genes that help regulate cell growth and division. The mutation is involved in many cancer types. “Today’s approval represents a significant step toward a future where more patients will have a personalized treatment approach,” Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement.