KRAZATI
Krazati (adagrasib) is an inhibitor of the RAS GTPase family indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic cancers. It is used as a single agent for patients with non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. It is also indicated for use in combination with cetuximab for patients with colorectal cancer (CRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. These indications received accelerated approval based on response rates, and continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How KRAZATI Works
Adagrasib is an irreversible inhibitor that targets the KRAS G12C mutant protein by covalently binding to its mutant cysteine. This binding locks the protein in an inactive state, which prevents downstream signaling and inhibits the growth and viability of tumor cells harboring the mutation. The drug is designed to target the mutant KRAS protein without affecting the wild-type KRAS protein. When used in combination with cetuximab, the therapy has shown increased antitumor activity in KRAS G12C-mutant colorectal cancer models compared to either drug used alone.
Details
- Status
- Prescription
- First Approved
- 2022-12-12
- Routes
- ORAL
- Dosage Forms
- TABLET
KRAZATI Approval History
What KRAZATI Treats
2 indicationsKRAZATI is approved for 2 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC)
- KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KRAZATI FDA Label Details
ProIndications & Usage
FDA Label (PDF)KRAZATI is an inhibitor of the RAS GTPase family indicated for: Non-small cell lung cancer (NSCLC)* • As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based che...
KRAZATI Patents & Exclusivity
Patents (5 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.