Oncology
FDA APPROVAL
● FDA Approval
FDA approves a new targeted cancer drug called Krazati for lung and colorectal cancers.
FDA
Published March 31, 2026
The U.S. Food and Drug Administration (FDA) has approved a new targeted cancer medicine called Krazati (adagrasib). It is approved for two uses. First, it can be used alone for adults with a specific type of advanced non-small cell lung cancer that has a genetic change called KRAS G12C, after they have tried at least one other treatment. Second, it can be used with another drug, cetuximab, for adults with advanced colorectal cancer that has the same KRAS G12C change, after they have tried certain types of chemotherapy.
This approval is important because it offers a new treatment option that directly targets this specific genetic change in the cancer cells. For many years, cancers with KRAS mutations have been very difficult to treat with targeted therapies. This drug is designed to block the faulty signal from this mutation that helps the cancer grow.
It is crucial to know that this drug is only for patients whose cancer has been confirmed to have the KRAS G12C mutation. A doctor will need to order a special test on a sample of the tumor or, for lung cancer, sometimes a blood sample, to check for this change before treatment can be considered.
The FDA granted this approval based on early data showing the drug could shrink tumors and that those responses lasted for a period of time. The agency will require further studies to confirm the drug's full benefits. As with any new treatment, patients interested in this option should have a detailed conversation with their oncology care team to understand if it might be right for their individual situation.
View Original Abstract ↓
1 INDICATIONS AND USAGE 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. ( 1.1 ) 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 chemotherapy. ( 1.2 ) *These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials. ( 1.1 , 1.2 ) 1.1 KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer KRAZATI, as a single-agent, is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received at least one prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) [see Clinical Studies (14.1) ]. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. 1.2 KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test [see Dosage and Administration (2.1) ] , who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR [see Clinical Studies (14.2) ] . Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial.
