FDA approves Tagrisso as adjuvant therapy for NSCLC subset
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The FDA approved osimertinib as adjuvant therapy for patients with non-small cell lung cancer with EGFR mutations.
Osimertinib (Tagrisso, AstraZeneca) — a third-generation, irreversible EGFR-directed tyrosine kinase inhibitor — already had been approved in the United States for first-line treatment of patients with metastatic NSCLC whose tumors harbor EGFR mutations.
The new indication applies to use of the agent after tumor resection by patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations as detected by an FDA-approved test.
The FDA based the approval on results of the randomized phase 3 ADAURA trial, which included 682 patients with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations who had undergone complete tumor resection with or without prior adjuvant chemotherapy.
Eligible patients had stage IB to stage IIIA tumors and predominantly nonsquamous histology.
Researchers randomly assigned patients to osimertinib 80 mg orally once daily or placebo after surgery recovery and standard adjuvant chemotherapy, if administered.
Investigator-assessed DFS among patients with stage II to stage IIIA NSCLC served as the major efficacy outcome measure. Researchers reported longer median DFS with osimertinib in this subgroup (not reached vs. 19.6 months; HR = 0.17; 95% CI, 0.12-0.23), as well as in the overall study population (not reached vs. 27.5 months; HR = 0.2; 95% CI, 0.15-0.27).
The most common adverse events among osimertinib-treated patients included lymphopenia, leukopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue and cough.
The FDA previously granted breakthrough therapy designation to osimertinib for this indication.
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