FDA Approves Krazati for KRAS G12C-Mutant Lung Cancer

Krazati was granted an accelerated approval for patients with KRAS G12C-mutant locally advanced or metastatic non-small cell lung cancer, according to the Food and Drug Administration.

The Food and Drug Administration (FDA) granted an accelerated approval to Krazati (adagrasib) for the treatment of adults with KRAS G12C-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC).

Patients must have received at least one prior systemic therapy and have their eligibility for the drug confirmed by an FDA-approved test — QIAGEN therascreen KRAS RGQ PCR kit (tissue) or the Agilent Resolution ctDx FIRST Assay (plasma) — which were also approved.

Krazati’s approval was based off findings from the KRYSTAL-1 trial, which involved 112 patients with locally advanced or metastatic KRAS G12C-mutant NSCLC that had progressed on or after platinum-based chemotherapy and immunotherapy that was given either together or sequentially.

The main goals of the study were objective response rate, which measures how much the tumors shrink, and duration of response (the time the disease responds to a treatment without growth or spread). Findings showed that the objective response rate was 43% and the average duration of response was 8.5 months.

The most common side effects that occurred in 20% or more of the study population included diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, liver injury, kidney impairment, difficulty breathing, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain and prolonged intervals between heartbeats.

Common laboratory abnormalities that occurred in at least 25% of patients were decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, decreased albumin, increased alanine aminotransferase, increased lipase, decreased platelets, decreased magnesium and decreased potassium.

The FDA is currently recommending that Krazati be prescribed in 600 mg tablets twice a day until disease worsens or patients experience unacceptable toxicity.

Since the drug was granted an accelerated approval, continued approval may be dependent on the results of future confirmatory trials.

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