KRAZATI adagrasib

Drug Class

KRAS G12C inhibitor

Mechanism

Covalently and irreversibly binds to KRAS G12C in its inactive GDP-bound state, preventing downstream signaling transduction.

Approved Indication

KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, and KRAS G12C-mutated colorectal cancer (in combination with cetuximab), per its FDA approval.

What This Means For Patients

Krazati is a targeted oral medication for patients with advanced non-small cell lung cancer or colorectal cancer harboring the KRAS G12C mutation. It helps block the aberrant signals that fuel tumor growth and is accessible under Hainan's special pilot policy.

Regulatory Approvals

• FDA — approved (2022) — label

Pivotal Clinical Evidence

• KRYSTAL-1 — Jänne et al., N Engl J Med 2022 (NCT03785249) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-adagrasib-kras-g12c-mutated-nsclc
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216340s000lbl.pdf