FDA Approves Sotorasib for NSCLC With KRAS Genetic Mutations


The FDA has approved sotorasib (Lumakras; Amgen Inc) for the treatment of non-small cell lung cancer in patients with KRAS G12C genetic mutations and who have received at least 1 prior therapy.

non-small cell lung cancer

The FDA has granted accelerated approval of sotorasib (Lumakras; Amgen Inc), the first treatment for non-small cell lung cancer (NSCLC) in patients whose tumors have genetic mutation KRAS G12C and who have received at least 1 prior systemic therapy.

KRAS mutations occur in a group of genes that aid in cell growth and division. These types of mutations account for an estimated 25% of all mutations found in NSCLC, 13% of which are GRAS 512C mutations.

Approval of sotorasib for this indication was based on a clinical trial that evaluated 124 patients with locally advanced or metastatic KRAS G12C-mutated NSCLC with disease progression after receiving an immune checkpoint inhibitor and/or platinum-based chemotherapy. The key outcomes of objective response rate – the proportion of patients whose tumor is destroyed or reduced – and duration of response of 6 months or more were 36% and 58%, respectively.

Based on available clinical data and pharmacokinetic and pharmacodynamic modeling, the FDA approved a 960-mg dose of sotorasib; however, the agency will also be requiring investigators to carry out a post-marketing trial in order to determine if a lower dose could be similarly beneficial.

The most common adverse effects of sotorasib include diarrhea, musculoskeletal pain, nausea, fatigue, liver damage, and cough. Health care professionals should be monitoring a patient’s liver function tests prior to starting treatment, according to the FDA.

“KRAS mutations have long been considered resistant to drug therapy, representing a true unmet need for patients with certain types of cancer,” said Richard Pazdur, MD, director, Oncology Center of Excellence, acting director, Office of Oncologic Diseases in the Center for Drug Evaluation and Research, FDA. “Today’s approval represents a significant step towards a future where more patients will have a personalized treatment approach.”

Sotorasib was approved using the FDA accelerated cpproval pathway, as well as fast track, priority review, and breakthrough therapy designations.


  1. FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy. News Release. FDA; May 28, 2021. Accessed June 1, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug.

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