Fda Approves Osimertinib For Adjuvant Therapy In Lung Cancer Patients

Adjuvant Osimertinib for EGFRm NSCLC Expert Think Tank on EGFRm NSCLC

What is Osimertinib?

Osimertinib is a targeted therapy drug used to treat non-small cell lung cancer (NSCLC) with specific genetic mutations. It is also known by its brand name, Tagrisso.

Adjuvant Therapy with Osimertinib

Adjuvant therapy is the use of additional treatment following the primary treatment to lower the risk of cancer returning. In December 2022, the FDA approved Osimertinib as an adjuvant therapy for patients with NSCLC who have undergone surgery and have EGFR mutations.

Clinical Trials

The FDA approval was based on the results of the ADAURA clinical trial. The trial showed that Osimertinib reduced the risk of cancer recurrence by 83% compared to a placebo. The trial also showed that patients who received Osimertinib had a longer disease-free survival period than those who received a placebo.

What are EGFR Mutations?

EGFR mutations are changes in the epidermal growth factor receptor gene that can cause cancer cells to grow and divide uncontrollably. EGFR mutations are found in about 10-15% of NSCLC cases.

Side Effects of Osimertinib

Common side effects of Osimertinib include diarrhea, skin rash, dry skin, nausea, and fatigue. In rare cases, Osimertinib can cause severe lung problems. Patients should report any new or worsening symptoms to their doctor immediately.


The FDA approval of Osimertinib as an adjuvant therapy for NSCLC patients with EGFR mutations is a significant advancement in cancer treatment. This approval provides a new option for patients to reduce the risk of cancer recurrence and improve their disease-free survival.


  • FDA Approves Osimertinib as Adjuvant Therapy for EGFR-Mutated NSCLC. OncLive. https://www.onclive.com/view/fda-approves-osimertinib-as-adjuvant-therapy-for-egfr-mutated-nsclc. Accessed January 31, 2023.
  • Osimertinib (Tagrisso). American Cancer Society. https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/osimertinib.html. Accessed January 31, 2023.
  • Results of ADAURA Trial Change the Standard of Care for Early-Stage EGFR-Mutated Lung Cancer. OncLive. https://www.onclive.com/view/results-of-adaura-trial-change-the-standard-of-care-for-early-stage-egfr-mutated-lung-cancer. Accessed January 31, 2023.