Is Sotorasib approved by the FDA?
Sotorasib, marketed under the brand name Lumakras, is a medication designed to treat non-small cell lung cancer (NSCLC). Sotorasib was granted FDA approval on May 28, 2021. This approval marked a significant milestone as it became the first approved targeted therapy for cancers with the KRAS G12C mutation, a common mutation in NSCLC. The approval was based on the drug's demonstrated overall response rate and duration of response in clinical trials.
Indications and Usage
Sotorasib is indicated for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. This mutation-specific treatment helps address the cancer in patients who have limited options after other therapies have failed. The medication works by inhibiting the mutated KRAS protein, thereby impeding cancer cell growth.
Administration
Sotorasib is administered orally and is typically taken once a day at a dose of 960 mg. The tablets should be swallowed whole, without crushing, chewing, or breaking them. Consistency in taking the medication with or without food is recommended.
Patients should follow specific instructions if they cannot swallow the tablets whole and should avoid taking another dose if they vomit shortly after ingestion. Additionally, certain antacids may interfere with the absorption of sotorasib, so it is crucial to take them either 4 hours before or 10 hours after the dose of sotorasib.
Side Effects and Warnings
Common side effects of sotorasib include:
- Nausea
- Diarrhea
- Cough
- Liver problems
- Muscle, joint, or bone pain
- Fatigue
Serious side effects that require immediate medical attention include:
- Breathing problems
- Severe ongoing nausea, vomiting, or diarrhea
- Unusual bleeding or bruising
- Liver problems, such as jaundice or dark urine
Patients should also be monitored for liver function regularly, and treatment may be delayed or discontinued based on side effect severity.
Precautions
Before starting sotorasib, patients should inform their doctor if they have a history of liver disease or other lung or breathing problems not related to cancer. The safety of sotorasib for pregnant or breastfeeding women has not been established, and patients are advised not to breastfeed during treatment and for at least one week after the last dose.
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