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FDA Approval Summary: Sotorasib for KRAS G12C -Mutated Metastatic NSCLC
Open accessAbstract
On May 28, 2021, the FDA granted accelerated approval to sotorasib (Lumakras, Amgen) for the treatment of adults with advanced non–small cell lung cancer (NSCLC) with a Kirsten rat sarcoma proto-oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy. The approval was based on CodeBreaK 100 (Study 20170543), a dose-escalation and dose-expansion trial in patients with an advanced, KRAS G12C-mutated, solid tumor. The overall response rate (ORR) observed in patients with KRAS G12C-mutated NSCLC treated with sotorasib (n = 124) was 36% [95% confidence interval (CI), 28–45]. The median duration of response was 10.0 months (95% CI, 6.9–not estimable). The most common adverse reactions (≥20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. This is the first approval of a targeted therapy for KRAS G12C-mutated NSCLC. Because of pharmacokinetic data and ORRs of patient cohorts who took sotorasib at lower doses in the dose-escalation portion of CodeBreaK 100, a dose comparison study is being conducted as a post-marketing requirement.
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“In 2021, the FDA approved sotorasib for the treatment of adult patients with KRAS G12C-mutated NSCLC, while adagrasib received similar approval the following year [48,50,51,52,53].”
From KRAS: Biology, Inhibition, and Mechanisms of Inhibitor Resistance (2024) · cites this paper as [52]
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Silencing effects of mutant RAS signalling on transcriptomes
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Identification of Covalent Ligands – from Single Targets to Whole Proteome
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Pulmonary Complications of Lung Cancer Treatment
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A Review of the in Silico Design and Development Approaches of Ras-Specific Anticancer Therapeutics
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“Because of mentioned complications and despite many efforts, only one FDA-approved medicine for K-Ras G12C mutant lung cancer, called Sotorasib, is available (Nakajima et al. 2022).”
Perspective Chapter: Evaluating New Drugs against K-Ras4B/PDE6δ Using an In Vitro Approach
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Liquid Biopsy in non-small cell lung cancer: exosomes as a tool for the study of biomarkers.
Sáez, M. E. D. (2024) · RiuNet (Universitat Politècnica de València) · doi:10.4995/thesis/10251/203438
Prognostic and Predictive Factors in Metastatic Colorectal Cancer
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Zhang, N., Li, Y., Cui, W., Yu, X., & Huang, Y. (2024) · Xenobiotica · doi:10.1080/00498254.2024.2377577
“Sotorasib (the first approved KRAS 12 c targeted drug) appears to be a typical case (Nakajima et al. 2022).”
Oscanoa, J., Ross‐Adams, H., Ullah, A. Z. M. D., Kolvekar, T. S., Sivapalan, L., Gadaleta, E., Thorn, G. J., Abdollahyan, M., Imrali, A., Saad, A. B., et al. (2024) · medRxiv · doi:10.1101/2024.07.25.24309825
“Targeted KRAS G12C inhibitor sotorasib has recently received FDA approval for treatment of mNSCLC 27 , and has been shown to be safe and effective in treatment of advanced mPDAC, in a Phase I/II trial in n=38 patients 28 .”
Mediating kinase activity in Ras-mutant cancer: potential for an individualised approach?
Healy, F. M., Turner, A. L., Marensi, V., & MacEwan, D. J. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1441938
Study of the mass balance, biotransformation, and safety of [14C]IBI351 in healthy Chinese subjects
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Targeted Agents and Immunotherapy
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ORGANOMETALLIC COMPOUND’S PHOTOTOXICITY AGAINST CANCER CELLS
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Predictive biomarkers for targeted therapy in daily anatomic pathology for ovarian tumors
Sureka, N., & Zaheer, S. (2025) · Surgical and Experimental Pathology · doi:10.1186/s42047-025-00187-3 · Cited by 2
“Sotorasib (Lumakras) received FDA approval in 2021 for non-small cell lung cancer (NSCLC) patients with the KRAS G12 C mutation (Nakajima et al. 2022).”
Bhattacharjee, P., Lahiri, A., Sindhwani, T., Reeves, N. P., & Datta, A. A. (2025) · IEEE Access · doi:10.1109/access.2025.3586246
“Direct targeting of mutant KRAS has been challenging, but recent developments like the KRAS G12C inhibitor: Sotorasib (Lumakras) offer promising therapeutic options [45].”
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Update on Drug-Induced Pneumonitis in Lung Cancer
McAvoy, K. A., & Possick, J. D. (2025) · Seminars in Respiratory and Critical Care Medicine · doi:10.1055/a-2666-7519
Corrêa, T. B., da Fonseca, G. L., Marques, R. B., Gomes-Filho, S. M., Hasenkamp, L. A., Magalhães, Y., Russo, L. C., Hoch, N. C., Forti, F. L., Levantini, E., et al. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/2025.09.29.679231
“Even though direct KRAS inhibitors have been recently approved for KRAS G12C -mutant lung cancer (5), KRAS G12C mutations are found in less than 2% of PDAC cases (6) and to date there are no specific KRAS -driven therapies approved for PDAC patients (4).”
Speranza, D., Marafioti, M., Musarra, M., Cianci, V., Omero, F., Spagnolo, C. C., Calabrò, M., Silvestris, N., Irrera, N., & Santarpía, M. (2025) · Pharmaceuticals · doi:10.3390/ph18101574
“Based on the favorable results of the CodeBreaK 100 trial, sotorasib received accelerated approval from the FDA on 28 May 2021 for the treatment of locally advanced or metastatic KRASG12C NSCLC [26].”
FragmentScope - exploring the fragment space with learned surface representationsPreprint
Elizarova, E., Morozova, I., Igashov, I., Gampp, O., Iosub, D. R. P., Schneuing, A., Lau, K., Ferraris, D. M., Pojer, F., Riek, R., et al. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.64898/2025.12.16.694391
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Rosell, R., Lewintre, E. J., Cao, P., Cai, X., Xing, B., Ito, M., Gomez-Vazquez, J. L., Marco-Jordán, M., Fariñas, S. C., Cardona, A. F., et al. (2024) · Figshare · doi:10.6084/m9.figshare.26027462
Barua, A., Kundu, S. T., Garza, S., Fradette, J. J., Choudhary, B. S., Peng, D. H., Diao, L., Wang, J., & Gibbons, D. L. (2025) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.64898/2025.12.22.696060
Cell wall target fragment discovery using a low‐cost, minimal fragment library
Yan, K., Stanley, M., Raimi, O. G., Ferenbach, A. T., Dorfmueller, H. C., & van Aalten, D. M. F. (2026) · FEBS Letters · doi:10.1002/1873-3468.70281
Ovarian Cancer Susceptibility and Chemosensitivity to KRAS Modulation
Psaras, A. M., McKay, S. J., Vilela, J. V., Sanchez, E. O., Cintrón, M. G., Elder, K. K., & Brooks, T. A. (2026) · International Journal of Molecular Sciences · doi:10.3390/ijms27031571
“Recent advances in direct and indirect KRAS inhibition—including FDA-approved KRAS G12C inhibitors sotorasib (2021) [18] and adagrasib (2022) [19], investigational KRAS G12D inhibitor MRTX1133 [20], and pan-KRAS inhibitors BI-2865 (GDP-state) and RMC-6236 (GTP-state) [21,22]—have opened new…”
Design, synthesis and biological evaluation of novel KRAS-G12D inhibitors
Baig, M. H., Jo, Y. S., Nale, S. D., Kim, C. J., Park, J., Ha, J., Moon, B., Ryu, S., & Dong, J.-J. (2026) · Journal of Enzyme Inhibition and Medicinal Chemistry · doi:10.1080/14756366.2025.2609342
“…a cause for concern 3,14,16–19 . the early success with KRas-G12c inhibitors has fuelled increased interest in targeting other KRas mutant forms 20,21 . however, it was not possible to immediately develop inhibitors for the other KRas oncogenic alleles. among these, the G12D mutation is the…”
Metadata
- Authors
- Nakajima, E. C., Drezner, N., Li, X., Mishra-Kalyani, P. S., Liu, Y., Zhao, H., Bi, Y., Liu, J., Rahman, A., Wearne, E., Ojofeitimi, I., Hotaki, L. T., Spillman, D., Pazdur, R., Beaver, J. A., & Singh, H.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Nakajima, Erica C.
- ORCID
- Venue
- Clinical Cancer Research
- Published
- 2021-12-10
- Volume
- 28
- Issue
- 8
- Pages
- 1482-1486
- ISSN
- 1078-0432 (ISSN-L)
- 1557-3265
- PMC
- PMC9012672
- OpenAlex
- W4200034683
- Cited by
- 333
- References
- 22
- Citations by year
- 2026: 45 · 2025: 78 · 2024: 84 · 2023: 85 · 2022: 41
- FWCI
- 33.96
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Cancer Research (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- HHS | U.S. Food and Drug Administration
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- sotorasib, KRAS G12C mutation, metastatic non-small cell lung cancer, accelerated FDA approval, targeted therapy, overall response rate, adverse effects, hepatotoxicity, dose comparison
- MeSH terms
- Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Mutation, Piperazines, Pyridines, Pyrimidines, Proto-Oncogene Proteins p21(ras), Clinical Trials, Phase I as Topic
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