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FDA Approvals, News & UpdatesLung Cancer

Tagrisso Approved as Adjuvant Therapy for Patients with Lung Cancer and EGFR Mutations

In December 2020, the FDA approved Tagrisso (osimertinib) for adjuvant therapy (continued therapy to prevent cancer recurrence) after surgical removal of the tumor, in patients with non–small-cell lung cancer and EGFR exon 19 deletions or exon 21 L858R mutations. Tagrisso was previously approved for the treatment of other types of lung cancer.
February 2021 Vol 7 No 1

In December 2020, the FDA approved Tagrisso (osimertinib; from AstraZeneca) for adjuvant therapy (continued therapy to prevent cancer recurrence) after tumor resection (surgical removal of the tumor) in patients with non–small-cell lung cancer (NSCLC) and EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The FDA approved this application 2 months ahead of the FDA’s goal date.

Tagrisso was previously approved for the first-line treatment of patients with metastatic NSCLC and EGFR exon 19 deletions or exon 21 L858R mutations, as well as for the second-line treatment of patients with metastatic NSCLC and EGFR T790M mutation.

The FDA approved this new indication for Tagrisso based on a clinical trial in 682 patients with NSCLC and EGFR exon 19 deletions or exon 21 L858R mutation who had complete tumor resection.

The patients were divided into 2 groups: 341 patients who received oral Tagrisso once daily and 341 patients who received placebo after recovery from the surgery (and if used, standard adjuvant chemotherapy).

In the patients with stage II to stage IIIA lung cancer, the average time without sign of disease was not reached in the Tagrisso groups, meaning that patients are still continuing to respond to therapy, compared with an average of 19.6 months in the placebo group. Among the total study population, the average time without any sign of disease again was still not reached in patients who received Tagrisso compared with 27.5 months in patients who received placebo, showing significant benefits with Tagrisso compared with placebo.

The most common side effects with Tagrisso were blood abnormalities, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.

Tagrisso is recommended to be used as adjuvant treatment of early-stage NSCLC once daily for up to 3 years, unless lung cancer comes back, or if the patient has unacceptable side effects.

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Last modified: March 3, 2021

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