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01-02-2023 | NSCLC | AdisInsight Report

Adagrasib: First Approval

Author: Sohita Dhillon

Published in: Drugs | Issue 3/2023

Abstract

Adagrasib (KRAZATI™) is an orally available, potent, irreversible, small molecule inhibitor of KRAS G12C mutant isoform being developed by Mirati Therapeutics for the treatment of solid tumours harbouring KRAS G12C oncogenic driver mutation, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Adagrasib covalently binds to the mutant cysteine in KRAS G12C and locks the mutant KRAS protein in its inactive state, thereby preventing downstream signalling without affecting wild-type KRAS protein. In December 2022, adagrasib received its first approval in the USA for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic NSCLC (as determined by an FDA approved test) who have received ≥ 1 prior systemic therapy. It was approved under accelerated approval based on objective response rate and duration of response, and its continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s). The drug is under regulatory review for NSCLC in the European Union and is in development for CRC in the US. Clinical studies of adagrasib in solid tumours, including CRC, are underway in several countries. This article summarizes the milestones in the development of adagrasib leading to this first approval for KRAS G12C-mutated locally advanced or metastatic NSCLC.

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Title: Adagrasib: First Approval
Author: Sohita Dhillon
Publication date: 01-02-2023
Publisher: Springer International Publishing
Keywords: NSCLC
NSCLC
Colorectal Cancer
Colorectal Cancer
Published in: Drugs / Issue 3/2023
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI: https://doi.org/10.1007/s40265-023-01839-y

2024 ASCO Annual Meeting

Springer Medicine

Adagrasib: First Approval

Abstract

2024 ASCO Annual Meeting

Springer Medicine

Abstract

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