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FDA Approval

FDA Approves Osimertinib for EGFR-Mutated NSCLC

December 21, 2020

On December 18, 2020, the FDA granted approval to osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after tumor resection for patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations.

The efficacy of osimertinib was demonstrated in the randomized, placebo controlled ADAURA trial, in which 682 patients with NSCLC who underwent complete tumor resection were randomized 1:1 to receive osimertinib or placebo.

Eligible patients with resectable tumors were required to have predominantly non-squamous histology and EGFR exon 19 deletions or exon 21 L858R mutations identified via the cobas® EGFR Mutation Test.

The major efficacy outcome measure was disease-free survival (DFS) specifically in patients with stage II-IIIA NSCLC determined by investigator assessment. In the osimertinib arm, DFS was not reached compared with 19.6 months in the placebo arm (HR 0.17 95% CI: 0.12, 0.23; P <.0001).

Additionally, in the overall study population, the median DFA was not reached in the osimertinib arm compared with 27.5 months in the placebo arm (HR 0.20 95% CI: 0.15, 0.27; P <.0001).

The most common adverse events associated with osimertinib, occurring in >20% of patients, were lymphopenia, leukopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough.—Janelle Bradley

Source: US Food and Drug Administration. FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations. December 18, 2020. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations. Accessed December 18, 2020.

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