FDA Grants Priority Review to Sotorasib for KRAS G12C NSCLC
Sotorasib receives FDA priority review for KRAS G12C non-small cell lung cancer (NSCLC), marking a pivotal step in targeted cancer treatment.
Medically Reviewed
by Dr. James Morrison, Chief Medical Officer (MD, FACP, FACC)
Reviewed on: April 04, 2026
The U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for sotorasib for patients with previously treated non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation, expediting the review process and highlighting the potential of this therapy to address a critical unmet need; this signals an important update in the potential **FDA sotorasib approval** timeline. The Priority Review designation shortens the FDA review process to a target of six months, compared to the standard ten months.
Drug Overview
Sotorasib is a small molecule kinase inhibitor and a first-in-class KRAS G12C inhibitor. It functions by selectively and irreversibly inhibiting the KRAS G12C mutant protein, locking it in an inactive GDP-bound state, thereby preventing downstream signaling through the MAPK pathway. Sotorasib received accelerated approval from the FDA in 2021 for the treatment of previously treated NSCLC harboring the KRAS G12C mutation.
Clinical Insights
Sotorasib's accelerated approval was based on data from the CodeBreaK 100 trial (NCT03600883), a Phase II trial. The primary endpoint of the trial was objective response rate (ORR). Common adverse events observed with sotorasib include diarrhea, nausea, fatigue, increased liver enzymes (transaminitis), and musculoskeletal pain.
Regulatory Context
The FDA granted Priority Review to the NDA for sotorasib, a designation for drugs that, if approved, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. This designation expedites the FDA review process to a target of six months instead of the standard ten months. Sotorasib received accelerated approval from the FDA in 2021.
Market Impact
Sotorasib competes with other KRAS G12C inhibitors such as adagrasib in the oncology market. KRAS G12C mutations occur in approximately 13% of NSCLC adenocarcinomas, representing a significant patient subset. Sotorasib offers an oral targeted therapy option for previously treated KRAS G12C-mutated NSCLC patients.
Future Outlook
The FDA's Priority Review for sotorasib may lead to further label expansions and potential combination trials.
Frequently Asked Questions
What is the KRAS G12C mutation?
The KRAS G12C mutation is a specific genetic alteration found in approximately 13% of NSCLC adenocarcinomas. It leads to the production of a mutant KRAS protein that drives cancer cell growth.
How does sotorasib work?
Sotorasib is a KRAS G12C inhibitor that selectively and irreversibly binds to the mutant KRAS G12C protein, locking it in an inactive state and preventing downstream signaling that promotes cancer growth.
What does Priority Review mean?
Priority Review is granted by the FDA to drug applications for therapies that, if approved, would represent a significant improvement in safety or efficacy in treating a serious condition. It shortens the FDA's review timeline.
References
References
- U.S. Food and Drug Administration. FDA approval. Accessed 2026-04-04.
Senior Medical Editor
Dr. Sarah Chen is a board-certified internist and former FDA clinical reviewer with 15+ years of experience in pharmaceutical regulatory affairs. She received her MD from Johns Hopkins and her PhD in ...
