FDA Approves Tagrisso as Adjuvant Therapy for Non-Small Cell Lung Cancer After Tumor Resection

The Food and Drug Administration (FDA) approved Tagrisso (osimertinib) for adjuvant therapy (given in addition to initial treatment) in patients with non-small cell lung cancer after undergoing tumor resection.

In particular, this drug is to be used as adjuvant therapy in patients with tumors that have particular epidermal growth factor receptor mutations or deletions based on test results.

This FDA approval was based on results from the ADAURA trial, which enrolled 682 patients and assigned them to either 80 mg of Tagrisso once per day or placebo after recovering from surgery. Median disease-free survival, the major efficacy outcome of the trial, was not reached in the Tagrisso group compared with 19.6 months in the placebo group. When assessed as a secondary efficacy outcome, the Tagrisso group also did not reach median disease-free survival versus 27.5 months in the placebo group.

According to the FDA’s release, the recommended dose of Tagrisso to treat early stage non-small cell lung cancer is 80 mg orally once per day either with or without food, and should be taken until unacceptable toxicity, disease recurrence or for up to three years.

Common adverse reactions, which may occur in at least 20% of patients, were leukopenia (low level of white blood cells), lymphopenia (reduction in a type of white blood cells), diarrhea, thrombocytopenia (low platelet levels), rash, anemia (low health blood cell counts), nail toxicity and musculoskeletal pain. Other common adverse reactions include neutropenia (low levels of neutrophils, a type of white blood cell), stomatitis (sore and inflamed mouth), dry skin, cough and fatigue.

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