The following quote is attributed to Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.
The Food and Drug Administration has approved the first drug for a specific mutation causing lung cancer in adult patients who have undergone at least one systemic treatment, such as chemotherapy.
FDA approval of Amgen drug sotorasib (Lumakras) makes the small molecule the first compound authorized by the regulator for treating cancers characterized by a KRAS G12C mutation. Mutated KRAS proteins had long been regarded "undruggable" targets.
The Food and Drug Administration approved Amgen's Lumakras drug as the first treatment for adult patients with a common form of lung cancer. Why it matters: Non-small cell lung cancer with a specific mutation in a gene known as KRAS has been considered to be resistant to any sort of drug treatment, per the FDA. Lumakras was able to shrink the tumors of between 36% and 58% of patients studied.Stay on top of the latest market trends and economic insights with Axios Markets. Subscribe for freeWhat they're saying: "Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach," said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA's Office of Oncologic Diseases.Details: The drug will target specifically KRAS G12C mutations, which comprise approximately 13% of mutations in non-small cell lung cancers, which is the most common type of lung
/PRNewswire/ Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung.