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ArticleFDA Updates

FDA approves first drug for lung cancer with KRAS mutation

Sotorasib (Lumakras), specifically targets the KRAS G12C mutation, which accounts for about 13% of NSCLC mutations. KRAS mutations are the most common mutations to occur in NSCLC tumors, accounting for about 25% of them, but for a long time, they appeared to be resistant to drug therapy.

Dose: 960 mg once daily

Side effects: The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity, and cough. The most common laboratory abnormalities (≥ 25%) were decreased lymphocytes, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, decreased calcium, increased alkaline phosphatase, increased urine protein, and decreased sodium.

Contraindications: Interstitial lung disease, CLD, along with drugs that are substrates of the P-glycoprotein.

Source: FDA

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