The U.S. Food and Drug Administration has approved Lumakras (sotorasib) as first treatment for non-small cell lung cancer patients whose tumors have specific type of genetic mutation called KRAS G12C. It is the first drug approved to treat KRAS-G12C which is a common mutation that researchers have struggled over the years to target. Amgen said that about 13% of people in USA with non-small cell lung cancer or about 25000 patients annually have the KRAS mutation that Lumakras treats.
This medication is designed to target a gene mutation which is called KRAS G12C. KRAS is a type of mutation in a group of genes that help to regulate cell growth. The researchers have evaluated the efficacy of Lumakras in a study of 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor.
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 said, “KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer.” “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach,” he added.
This FDA approved drug by Amgen, sotorasib, will be sold under the brand name Lumakras and helped to shrink tumors with KRAS mutation in about 36% of patients in clinical trials. Amgen said that the drug will have U.S list price of $17900 per month. This approval is for a daily 960 milligram pill and is based on available clinical data as well as pharmacokinetic and pharmacodynamic modeling that support the approved dose.
The common side effects that come with Lumakras are diarrhea, nausea, liver damage, musculoskeletal pain, and cough. This approval is the latest advance from cancer research field that delivered many new targeted therapies over the past few years.
The information shared in this blog is solely for educational purposes and is certainly not a substitute for medical advice.