FDA Approves Breakthrough KRAS Inhibitor Lumakras for Lung Cancer
The FDA has approved Lumakras, a groundbreaking KRAS inhibitor, providing a new targeted therapy option for patients battling lung cancer.
Medically Reviewed
by Dr. James Morrison, Chief Medical Officer (MD, FACP, FACC)
Reviewed on: March 30, 2026
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sotorasib (Lumakras) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. The approval, announced on May 28, 2021, marks a historic milestone as the first targeted therapy for KRAS G12C mutations, which occur in approximately 13% of NSCLC cases.
The breakthrough designation addresses a significant unmet need in NSCLC treatment, where KRAS mutations have long been considered "undruggable." Sotorasib works by specifically inhibiting KRAS G12C, a protein that drives cancer growth.
Pivotal Trial Results
The FDA's decision was based on results from the CodeBreaK 100 trial (NCT03600883), which demonstrated compelling efficacy in previously treated NSCLC patients. The study showed:
- Objective response rate (ORR) of 36% (95% CI: 28-45)
- Median duration of response of 10 months
- Disease control rate of 81%
- Median progression-free survival of 6.8 months
Safety Profile
The safety analysis included 359 patients who received sotorasib 960 mg daily. The most common adverse reactions (≥ 20%) included:
- Diarrhea (42%)
- Musculoskeletal pain (35%)
- Nausea (25%)
- Fatigue (21%)
Clinical Impact and Implementation
Dr. Roy Herbst, Chief of Medical Oncology at Yale Cancer Center, commented: "The approval of sotorasib represents a significant advancement in precision medicine for lung cancer. This targeted therapy offers new hope for patients with KRAS G12C mutations who previously had limited treatment options."
The drug manufacturer has announced that sotorasib will be available through specialty pharmacies within one week of approval. The recommended dose is 960 mg (eight 120 mg tablets) taken orally once daily.
Frequently Asked Questions
Who is eligible for sotorasib treatment?
Adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy are eligible. Patients must undergo FDA-approved testing to confirm the presence of the KRAS G12C mutation.
How is KRAS G12C mutation testing performed?
The FDA has approved the Qiagen therascreen KRAS RGQ PCR kit and the Guardant360 CDx as companion diagnostics for sotorasib.
Future Development
Ongoing clinical trials are investigating sotorasib in various combinations and earlier treatment settings. The confirmatory Phase 3 CodeBreaK 200 trial (NCT04303780) comparing sotorasib to docetaxel in KRAS G12C-mutated NSCLC is currently enrolling patients.
The manufacturer is required to submit additional clinical data to the FDA as part of the accelerated approval process to confirm the drug's clinical benefit.
References
- U.S. Food and Drug Administration. FDA approval. Accessed 2026-03-30.
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 ...
