The Food and Drug Administration (FDA) has granted Priority Review to osimertinib (Tagrisso®; AstraZeneca) for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
The sNDA is supported by data from the randomized, double-blind, placebo-controlled phase 3 ADAURA trial (N=682) that assessed the efficacy and safety of osimertinib in patients with early-stage EGFRm NSCLC after complete tumor resection with or without adjuvant chemotherapy. Patients were randomized 1:1 to receive either osimertinib 80mg orally once daily or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease.
Results showed that treatment with osimertinib reduced the risk of disease recurrence or death by 83% (hazard ratio (HR) 0.17 [95% CI, 0.12-0.23]; P <.0001) in patients with stage II to IIIA disease. In the overall population (stages IB through IIIA), treatment with osimertinib reduced the risk of disease recurrence or death by 79% (HR 0.21 [95% CI, 0.16-2.8]; P <.0001).
“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “This expedited review underscores the unprecedented disease-free survival benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible.”
Tagrisso is currently indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. It is also approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.