Summary
- On September 25, 2024, the FDA approved osimertinib for adult patients with certain types of non-small cell lung cancer that has not progressed after certain treatments.
- Osimertinib showed significant improvement in progression-free survival compared to a placebo in a clinical trial.
- The most common side effects of osimertinib included lymphopenia, rash, diarrhea, musculoskeletal pain, and others.
- The recommended dose of osimertinib is 80 mg once daily until disease progression or unacceptable toxicity.
- The FDA collaborated with international partners for this drug review, and the FDA expedited the review process due to the seriousness of the condition.
The Food and Drug Administration recently approved osimertinib (Tagrisso) for adult patients with locally advanced non-small cell lung cancer (NSCLC). This approval is specifically for patients whose disease has not progressed following treatment with platinum-based chemoradiation therapy and who have certain genetic mutations. Osimertinib has shown significant improvement in progression free survival compared to a placebo in clinical trials.
In addition to the approval for osimertinib, the FDA also collaborated with international partners for this review as part of Project Orbis. This initiative aims to streamline the review process for oncology drugs among different regulatory agencies. Healthcare professionals are encouraged to report any adverse events related to the use of this medication to the FDA. Overall, this approval marks a significant advancement in the treatment options available for patients with locally advanced NSCLC.
Oncology, Pulmonary Medicine