FDA Approval Summary: Sotorasib for KRAS G12C -Mutated Metastatic NSCLC
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 bas...
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| Published in | Clinical cancer research Vol. 28; no. 8; pp. 1482 - 1486 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
14.04.2022
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| Subjects | |
| Online Access | Get full text |
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| Abstract | 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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| AbstractList | On May 28, 2021, the U.S. Food and Drug Administration (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% CI 28, 45). The median duration of response (DOR) 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. Due to 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 (PMR). 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. 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.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. |
| Author | Wearne, Emily Spillman, Dianne Drezner, Nicole Liu, Yajun Beaver, Julia A. Pazdur, Richard Hotaki, Lauren Tesh Zhao, Hong Li, Xiaoxue Mishra-Kalyani, Pallavi S. Liu, Jiang Singh, Harpreet Bi, Youwei Nakajima, Erica C. Ojofeitimi, Idara Rahman, Atiqur |
| AuthorAffiliation | 2 Oncology Center of Excellence, U.S. Food and Drug Administration 1 Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
| AuthorAffiliation_xml | – name: 2 Oncology Center of Excellence, U.S. Food and Drug Administration – name: 1 Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
| Author_xml | – sequence: 1 givenname: Erica C. surname: Nakajima fullname: Nakajima, Erica C. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 2 givenname: Nicole surname: Drezner fullname: Drezner, Nicole organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 3 givenname: Xiaoxue surname: Li fullname: Li, Xiaoxue organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 4 givenname: Pallavi S. surname: Mishra-Kalyani fullname: Mishra-Kalyani, Pallavi S. organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 5 givenname: Yajun surname: Liu fullname: Liu, Yajun organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 6 givenname: Hong surname: Zhao fullname: Zhao, Hong organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 7 givenname: Youwei surname: Bi fullname: Bi, Youwei organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 8 givenname: Jiang surname: Liu fullname: Liu, Jiang organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 9 givenname: Atiqur surname: Rahman fullname: Rahman, Atiqur organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 10 givenname: Emily surname: Wearne fullname: Wearne, Emily organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 11 givenname: Idara surname: Ojofeitimi fullname: Ojofeitimi, Idara organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 12 givenname: Lauren Tesh orcidid: 0000-0001-9674-8424 surname: Hotaki fullname: Hotaki, Lauren Tesh organization: Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 13 givenname: Dianne orcidid: 0000-0001-6127-4759 surname: Spillman fullname: Spillman, Dianne organization: Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 14 givenname: Richard surname: Pazdur fullname: Pazdur, Richard organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 15 givenname: Julia A. surname: Beaver fullname: Beaver, Julia A. organization: Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland – sequence: 16 givenname: Harpreet surname: Singh fullname: Singh, Harpreet organization: Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/34903582$$D View this record in MEDLINE/PubMed |
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| Snippet | 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... 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... On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib (Lumakras™, Amgen) for the treatment of adults with... |
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| SubjectTerms | Carcinoma, Non-Small-Cell Lung - drug therapy Carcinoma, Non-Small-Cell Lung - genetics Clinical Trials, Phase I as Topic Humans Lung Neoplasms - chemically induced Lung Neoplasms - drug therapy Lung Neoplasms - genetics Mutation Piperazines - therapeutic use Proto-Oncogene Proteins p21(ras) - genetics Pyridines Pyrimidines |
| Title | FDA Approval Summary: Sotorasib for KRAS G12C -Mutated Metastatic NSCLC |
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