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Adjuvant Osimertinib Approved by FDA for EGFR-Mutated Lung Cancer

By: Jocelyn Solis-Moreira, MS
Posted: Wednesday, December 23, 2020

On December 18, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) for adjuvant therapy after tumor resection in patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. In 2018, osimertinib was approved for first-line treatment of patients with metastatic NSCLC whose tumors have these genetic mutations.

The FDA approval was based on a double-blind clinical trial that evaluated 682 patients with early-stage NSCLC with either EGFR exon 19 deletions or exon 21 L858R mutation who had undergone complete tumor removal. A total of 339 patients received osimertinib orally once daily, and 343 patients received a placebo following recovery from surgery and standard adjuvant chemotherapy, if given.

The main outcome measure was disease-free survival. Results showed an 80% decrease in disease recurrence in patients given osimertinib compared with those given a placebo. The most common side effects reported with osimertinib in this study included diarrhea, rash, musculoskeletal pain, dry skin, nail toxicity, sore mouth, fatigue, and cough.

The recommended osimertinib dose for adjuvant treatment of early-stage NSCLC is 80 mg orally once daily, with or without food, until disease recurrence, unacceptable toxicity, or for up to 3 years.



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