(RxWiki News) The US Food and Drug Administration (FDA) has approved a new lung cancer treatment that targets a common tumor mutation.
This new medication is called Lumakras (sotorasib). The FDA approved it to treat adults who have non-small cell lung cancer (NSCLC).
More specifically, this drug is approved to treat NSCLC that has tumors with a genetic mutation called KRAS G12C. This is the first drug targeted to treat tumors with any kind of KRAS mutation, the FDA noted.
“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA's Office of Oncologic Diseases, in a press release. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”
According to the FDA, around 13 percent of mutations seen in NSCLC tumors are KRAS G12C tumors. That's the type of tumor the FDA has approved Lumakras to treat.
This approval was based on the results of a study of 124 people who had advanced KRAS G12C-mutated NSCLC and received Lumakras. These patients had already received other cancer treatments that did not appear to work.
In around 36 percent of the study patients who took Lumakras, tumors shrank or completely went away. And 58 percent of the patients who saw this kind of response had the response last for at least six months.
Cough, liver damage, nausea, diarrhea, fatigue and body pain were the most common side effects of Lumakras, according to the FDA. Those who take this drug should not take any acid-reducing medications or drugs that affect the liver.
Health care providers should monitor patients taking Lumakras for liver damage and interstitial lung disease, the FDA said.
Talk to your health care provider about the best available treatment for your condition.
The FDA approved this medication for Amgen Inc.