Updated January 8th, 2025

FDA Approves First Targeted Therapy For Lung Cancer Patients With The KRAS Gene Mutation – Extraordinary Results With Sotorasib

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FDA Approves Sotorasib

The Food and Drug Administration approved sotorasib (brand name: Lumakras) for non-small cell lung cancer patients with the KRAS genetic mutation.
In clinical trials, sotorasib shrank tumors with the KRAS mutation in around 36% of patients with 81% of patients achieving disease control (complete response, partial response or stable disease).
KRAS mutations have long been considered resistant to drug therapy, according to doctors.

There is finally a new treatment for people with lung cancer that is particularly resistant to treatment because it contains a genetic mutation called KRAS. The Food and Drug Administration (FDA) approved a drug called sotorasib (brand name: Lumakras) for lung cancer patients whose tumors have a mutation called KRAS G12C and whose cancer has spread even after treatment with chemotherapy or other medications.

When initial results of early sotorasib trials were released in February, oncologists greeted the news with excitement.

Dr. Roy Herbst, chief of medical oncology at Yale, told SurvivorNet: “We are excited we have a drug that could work in these patients. The fact that tumors respond to this therapy is a big deal.” Dr. Herbst also said he is optimistic about the future of drugs targeting KRAS and thinks the results of this study “opens up a whole new world for lung cancer.”

The approval is for people with Non Small Cell Lung Cancer (NSCLC) which makes up about 84% of lung cancers, according to the American Cancer Society. The KRAS G12C gene mutation occurs in about 13% of NSCLCs.

RELATED: First Targeted Lung Cancer Treatment for Patients with KRAS Mutation Sees Remarkable Trial Results

In clinical trials, sotorasib shrank tumors with the KRAS mutation in around 36% of patients with 81% of patients achieving disease control (complete response, partial response or stable disease).

“KRAS has challenged cancer researchers for more than 40 years with many deeming it as ‘undruggable’,” Dr. David M. Reese, executive vice president of Research and Development at Amgen, said in a press release. “The LUMAKRAS development program was a race against cancer for Amgen’s scientists and clinical trial investigators who together have now successfully delivered this new medicine to patients in less than three yearsfrom first patient dosed to U.S. regulatory approval.”

"KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in press release. "Today's approval represents a significant step towards a future where more patients will have a personalized treatment approach."

The most common side effects of Lumakras include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage and cough.

What This Means for Patients

Most patients will have their tumor tested for genetic abnormalities or biomarkers to help their doctors select which treatments are best. Some common biomarkers such as EGFR and PDL1 have medications that doctors can use to target the lung cancer and improve a patient's survival and quality of life. Despite this, one biomarker that has never had a treatment is KRAS.

KRAS is a mutation that occurs in some patients with NSCLC and is generally associated with poor outcomes. One reason this mutation is considered a bad risk factor is that unlike other mutations such as EGFR there has never been a drug approved to treat this type of lung cancer. This changes with sotorasib.

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