The DOI matches its Crossref record; 21 of the 22 references it cites were found in a registry or an index.
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.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
The Clinical KRAS(G12C) Inhibitor AMG 510 Drives Anti-Tumour Immunity
Canon, J., Rex, K., Saiki, A. Y., Mohr, C., Cooke, K., Bagal, D., Gaida, K., Holt, T., Knutson, C. G., Koppada, N., et al. (2019) · Nature · doi:10.1038/s41586-019-1694-1 · Cited by 2,277
Shepherd, F. A., Dancey, J. E., Ramlau, R., Mattson, K. V., Gralla, R. J., O’Rourke, M. A., Levitan, N. I., Gressot, L., Vincent, M. D., Burkes, R. L., et al. (2000) · Journal of Clinical Oncology · doi:10.1200/jco.2000.18.10.2095 · Cited by 2,178
RAS Proteins and Their Regulators in Human Disease
Simanshu, D. K., Nissley, D. V., & McCormick, F. (2017) · Cell · doi:10.1016/j.cell.2017.06.009 · Cited by 1,943
The Ras-RasGAP Complex: Structural Basis for GTPase Activation and Its Loss in Oncogenic Ras Mutants
Scheffzek, K., Ahmadian, M. R., Kabsch, W., Wiesmüller, L., Lautwein, A., Schmitz, F., & Wittinghofer, A. (1997) · Science · doi:10.1126/science.277.5324.333 · Cited by 1,543
Garon, E. B., Ciuleanu, T.-E., Arrieta, O., Prabhash, K., Syrigos, K. N., Goksel, T., Park, K., Gorbunova, V., Kowalyszyn, R. D., Pikiel, J., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(14)60845-x · Cited by 1,309
RAS-targeted therapies: is the undruggable drugged?
Moore, A. R., Rosenberg, S. C., McCormick, F., & Malek, S. (2020) · Nature Reviews Drug Discovery · doi:10.1038/s41573-020-0068-6 · Cited by 1,103
Direct small-molecule inhibitors of KRAS: from structural insights to mechanism-based design
Ostrem, J. M. L., & Shokat, K. M. (2016) · Nature Reviews Drug Discovery · doi:10.1038/nrd.2016.139 · Cited by 641
Chang, E. H., Gonda, M. A., Ellis, R. W., Scolnick, E. M., & Lowy, D. R. (1982) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.79.16.4848 · Cited by 324
The Drug-Dosing Conundrum in Oncology — When Less Is More
Shah, M., Rahman, A., Theoret, M. R., & Pazdur, R. (2021) · New England Journal of Medicine · doi:10.1056/nejmp2109826 · Cited by 298
Self-citationDistribution of KRAS G12C Somatic Mutations across Race, Sex, and Cancer Type
Nassar, A. H., Adib, E., & Kwiatkowski, D. J. (2021) · New England Journal of Medicine · doi:10.1056/nejmc2030638 · Cited by 210
Research works printed but not linked: 2
- Herbst, 2019, Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042, Ann Oncol, 30, X163
- U.S. Food and Drug Administration, NDA Multi-disciplinary Review and Evaluation (NDA 214665) and Approval Package: LUMAKRAS (sotorasib)
Cited by
Sorted by citations
Items 301–333 of 333
Wang, J., Jiang, L.-L., Wang, M., & Li, Y.-L. (2026) · Drug Design Development and Therapy · doi:10.2147/dddt.s600434 · Cited by 1
Steendam, C. M. J., Meijers, R. W. J., Atmodimedjo, P. N., van Dijk, L., van der Leest, C., van Loenhout, K. C. J., Westeinde, S. C. V. ‘., Dumoulin, D. W., Hanselaar, W. E. J. J., Paats, M. S., et al. (2026) · Scientific Reports · doi:10.1038/s41598-026-47197-z
Diacylglycerol Kinase Eta as a Novel Target in NRAS Mutant Melanoma
Wilson, H. P., Stefanski, C. D., Caksa, S., Mersky, G. L., Varney, S. D., Haj, J. I., Erkes, D. A., Purwin, T. J., Chua, V., & Aplin, A. E. (2026) · Pigment Cell & Melanoma Research · doi:10.1111/pcmr.70090
“…et al. 2021; De Langen et al. 2023; Dhillon 2023; Du et al. 2024; Hallin et al. 2022; Hunter et al. 2014; Janes et al. 2018; Jänne et al. 2022; Nagashima et al. 2022; Nakajima et al. 2022; Ostrem et al. 2013; Patricelli et al. 2016; Tolcher et al. 2023; Wang, Allen, et al. 2021; Zhou et al. 2023).”
Li, Y., Zhou, M., Pan, J., Su, H., Song, M., Guan, Z., Zhao, D., Zhao, X., Zhao, Y., Chen, P., et al. (2026) · Translational Oncology · doi:10.1016/j.tranon.2026.102821
“Existing studies have demonstrated that AMG510 has favorable efficacy against non-small cell lung cancer and colorectal cancer [17 – 19].”
Somatic Alterations in TP53 and KRAS and Their Functional Impact in Epithelial Ovarian Cancer
Meyer, L., Schmid, A., & Braun, S. (2025) · Asian journal of Current Research in Clinical Cancer · doi:10.51847/wmtwatdftw
Jiang, L., Luo, Y., Liang, H., Feng, X., Huang, Y., Li, Y., Wang, Z., Xu, T., Zou, H., Li, Z., et al. (2026) · Human Cell · doi:10.1007/s13577-026-01405-0
“…of allele-specific covalent inhibitors, such as sotorasib and adagrasib that trap KRAS G12C in its inactive GDP-bound state, has revolutionized the therapeutic landscape for KRAS G12C mutant cancers, demonstrating clinically meaningful efficacy and leading to regulatory approvals [1, 7, 8].”
Bagde, P. H., Deb, B., Shrivastava, H., & Jha, H. C. (2026) · Springer eBooks · doi:10.1007/978-981-95-9777-2_13
Benefits and challenges of adding BKM120 to a BI-3406 plus trametinib combination therapy
Schulz, B., Leitner, E., Rabierad, M., Khan, M. I., Ehlers, L., Escobar, H. M., Jaster, R., Vollmar, B., & Zechner, D. (2026) · BMC Cancer · doi:10.1186/s12885-026-16409-0
“Sotorasib, which inhibits the KRAS G12C mutation, was approved in 2021 for patients with advanced non-small cell lung cancer [4].”
Harnessing tumor-agnostic biomarkers for precision medicine in lymphoma
Lee, Y., Lim, N.-A., Kwan, R. L. Y., & Chan, J. H. (2026) · Cancer Treatment and Research Communications · doi:10.1016/j.ctarc.2026.101312
Zhou, X., Du, H., Yang, H., Hu, Y., Wang, C., Zhang, M., Ding, X., & Wang, P. (2026) · Frontiers in Chemistry · doi:10.3389/fchem.2026.1879034 · Cited by 1
“…2020), whose clinical efficacy was demonstrated in phase I and II trials (Hong et al., 2020; Skoulidis et al., 2021) and ultimately supported its U.S. Food and Drug Administration (FDA) approval as the first targeted therapy for KRAS G12C-mutated non-small-cell lung cancer (Nakajima et al., 2022).”
Salih, R., Sirajudeen, F., & Rahmani, M. (2026) · Journal of Advanced Research · doi:10.1016/j.jare.2026.08.030
The role of FGFR signaling in SCLC and NSCLC: Current insights and therapeutic perspectives
Kim, B., Lee, G. T., Jeong, M., Choi, H., & Kim, K.-B. (2026) · iScience · doi:10.1016/j.isci.2026.117135
Callegarin, M., Angerilli, V., Gasparello, J., Bergamo, F., Cuestas, R. H. G., Parente, P., Lonardi, S., & Fassan, M. (2026) · Cancers · doi:10.3390/cancers18162602
“%) harbored a c.G12C point-mutation, which can be targeted by KRAS-G12C inhibitors such as sotorasib, currently approved by the FDA for NSCLC and CRC [50].”
Piekarz, J., Picheta, N., Pobideł, J., Gierulska, N., Kłodnicka, K., Januszewski, J., Szklener, K., & Skórzewska, M. (2026) · Frontiers in Oncology · doi:10.3389/fonc.2026.1916211
Pilco‐Janeta, D. F., Puebla, M. D. L. C., Guamán-Pilco, D. R., Montenegro, D., & Miranda, W. (2026) · Cancer Research Communications · doi:10.1158/2767-9764.crc-26-0322
“Regulatory summaries and clinical trials have established sotorasib and adagrasib as KRAS G12C–directed therapies in previously treated advanced or metastatic NSCLC (5, 6, 16, 17).”
Regulatory considerations for anticancer drug delivery systems
Bharti, K., Deepika, D., & Kumar, V. (2026) · Elsevier eBooks · doi:10.1016/b978-0-443-44185-1.00002-1
Li, L., Li, J., Yang, L., Zhou, J., & Ma, Y. (2026) · Pharmaceuticals · doi:10.3390/ph19091388
“This view changed with the development of first-generation KRAS inhibitors, represented by the FDA-approved agents sotorasib and adagrasib [16,17].”
Chen, Y.-L., Chen, W.-C., Yeh, T., Ho, H.-H., Chen, T.-C., & Wang, W. (2026) · Biomedical Journal · doi:10.1016/j.bj.2026.101036
Sheffield, K. M., Puri, T., Thoele, K., Karu, H., Mansharamani, A., & Uprety, D. (2026) · Cancers · doi:10.3390/cancers18172869 · Cited by 1
“Two KRAS G12C inhibitors, sotorasib and adagrasib, have received accelerated approval from the FDA for patients with KRAS G12C-mutant NSCLC who have received at least one prior therapy [17,18].”
Advances in KRAS-Targeted Therapies for Pancreatic Cancer
Peshin, S., Zahid, A., Takrori, E., Hamedi, Z., & Rahman, S. (2026) · Cancers · doi:10.3390/cancers18182961
“Sotorasib was the first to enter clinical trials and receive FDA approval for KRAS -G12C-mutant non-small-cell lung cancer (NSCLC) [22].”
RAS/RAF/MAPK Alterations in Prostatic Adenocarcinoma: A Multi-Institutional Study
Chan, G. J., Zhu, X., Kwon, J. W., Tjota, M. Y., Wuori, D., Korentzelos, D. K., Mohebnasab, M., Greenland, N., Stohr, B. A., Simko, J., et al. (2026) · Human Pathology · doi:10.1016/j.humpath.2026.106270
Chemoproteomics in covalent cancer drug discovery
Ong, J.-P., Dalziel, M., Johns, D., Zhu, J., & Bertoldo, J. B. (2026) · Drug Discovery Today · doi:10.1016/j.drudis.2026.104817
Zhang, L., Jiang, S., Yan, W., Cao, W., Wang, X., Wang, W., Zhang, B., & Wei, T. (2026) · Clinical & Translational Oncology · doi:10.1007/s12094-026-04572-6
Oncology Dose Optimization Trials
He, P., Mi, G., Zhang, Z., Chakravartty, A., Mitchell, P., D’Angelo, G., Ma, H., Mishra, K., & Colin, P. (2026) · Springer eBooks · doi:10.1007/978-981-95-9518-1_4
Ding, L., Staskiewicz, A., Kao, J., & Wang, X. (2026) · Frontiers in Pharmacology · doi:10.3389/fphar.2026.1960752
Mall, T., Bachhar, V., Joshi, V., Lin, M., Wu, C., Hung, C.-H., Tsai, C.-I., Chang-Chien, G.-P., & Kogularasu, S. (2026) · Pathology - Research and Practice · doi:10.1016/j.prp.2026.156711
Poswal, J., Tejavath, K. K., Kushwaha, V., Vidya, R. S., Banavath, H. N., Dey, S. K., & Mandal, C. C. (2026) · Biochimica et Biophysica Acta (BBA) - Molecular and Cell Biology of Lipids · doi:10.1016/j.bbalip.2026.159779
BindingDB (2024) · UC San Diego · doi:10.7270/q2m61qmd
BindingDB (2026) · UC San Diego · doi:10.7270/q2t4401d
BindingDB (2026) · UC San Diego · doi:10.7270/q27p94b7
BindingDB (2024) · UC San Diego · doi:10.7270/q22n56qk
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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
