On December 18th, 2020, the Food and Drug Administration (FDA) approved Tagrisso (osimertinib) for the adjuvant treatment of stage IB-IIIA non-small cell lung cancer (NSCLC) that has been surgically removed, when the cancer has a change in EGFR. The FDA based their approval on the results of the clinical trial ADAURA which showed that patients receiving Tagrisso (osimertinib) lived longer without a recurrence than patients who did not take the drug.

This is the first approval of a targeted therapy that a person with lung cancer would take in the adjuvant setting –after surgery, to prevent the cancer from recurring. This is different from many other FDA approvals that are only for stage IV metastatic cancer. Tagrisso (osimertinib) being available for patients without metastatic disease creates a new opportunity for early stage patients whose cancer has a driver mutation to receive targeted adjuvant therapy where before the only options were chemotherapy or immunotherapy.

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