The FDA accepts the first drug aimed at the common mutation of lung cancer


by Linda A. Johnson

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

The Food and Drug Administration announced Friday that it has approved Amgen’s Lumakras drug to treat people who are not with the mutation in patients who have worsened since with at least one other medication. Each year, about 13,000 American patients are diagnosed with this cancer and this mutation.

This is the first tumor-targeted therapy with the 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 types of cancer.

“Today’s approval represents a significant step toward a future where more patients have a personalized treatment approach,” Dr. Richard Pazdur, director of the FDA’s Center for Oncological Excellence, said in a statement.

Amgen said Lumakras, also known as sotorasib, will cost $ 17,900 a month, although most patients will pay less, depending on health insurance and other factors. Lung cancer is the most common type of cancer and is the leading cause of cancer deaths in the US.

The agency also approved of two companies that can determine if patients have the specific mutation, known as KRAS G12C, the drug’s target.

Amgen and other drug manufacturers are working to develop several drugs designed to attack tumors with KRAS mutations.

“KRAS has challenged researchers for more than 40 years, ”said Dr. David M. Reese, head of research and development at Amgen.

The FDA approved the drug on an accelerated schedule, based only on the first results of the study, due to its potential and lack of options for these patients. It requires additional testing to confirm the benefit of the drug.

In a study that included 124 patients, 36% had tumors shrunk or gone. Improvements lasted six months or more for nearly 60% of beneficiaries.

The most common side effects were diarrhea, joint and muscle pain, fatigue and liver damage. The FDA said the drug should be discontinued if patients develop liver damage or some type of lung disease.

Immunotherapy alone prolonged the life of patients with metastatic lung cancer with KRAS mutation

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