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...

Full description

Saved in:
Bibliographic Details
Published in:Clinical cancer research 2022-04, Vol.28 (8), p.1482-1486
Main Authors: Nakajima, Erica C, Drezner, Nicole, Li, Xiaoxue, Mishra-Kalyani, Pallavi S, Liu, Yajun, Zhao, Hong, Bi, Youwei, Liu, Jiang, Rahman, Atiqur, Wearne, Emily, Ojofeitimi, Idara, Hotaki, Lauren Tesh, Spillman, Dianne, Pazdur, Richard, Beaver, Julia A, Singh, Harpreet
Format: Article
Language:English
Subjects:
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
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.ccr-21-3074