First KRAS-Targeted Therapy Receives FDA Approval for Lung Cancer

November 24, 2021 by Elisa Becze BA, ELS, Editor

Sotorasib offers a durable clinical benefit without new safety signals in patients with previously treated KRAS p.G12C-variant non-small cell lung cancer, according to the results of a clinical trial that led to the therapy’s U.S. Food and Drug Administration (FDA) approval. The researchers reported ( the findings in the New England Journal of Medicine.

In the phase II, single-arm trial, researchers evaluated responses from 124 patients who received 960 mg of sotorasib orally once daily. The majority (81%) had previously received both platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.

A total of 46 patients (37.1%) had an objective response for a median of 11.1 months. Comparatively, 100 patients (80.6%) achieved disease control. The median progression-free survival was 6.8 months and median overall survival 12.5 months. Treatment­related adverse events occurred in 88 patients (69.8%), including grade 3 events in 25 patients (19.8%) and a grade 4 event in 1 (0.8%).

Although the study was conducted only among patients with non-small cell lung cancer, the findings have broader implications for other types of cancer and disease sites. KRAS variants are involved ( in approximately 25% of all cancers across sites like non-small cell lung, colorectal, and pancreatic cancer. Until sotorasib’s approval for non-small cell lung cancer, clinicians had no pharmaceutical options to treat KRAS-variant cancers.

For more information about sotorasib and its nursing considerations, review ONS’s oncology drug reference sheet. (

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