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FDA grants priority review to Tagrisso for EGFR-positive non-small cell lung cancer

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The FDA granted priority review to osimertinib for the first-line treatment of epidermal growth factor receptor-positive metastatic non-small cell lung cancer, according to a press release from the agent’s manufacturer.

The agency based the designation on results of the phase 3 FLAURA trial, presented in September at European Society for Medical Oncology Congress and published simultaneously in The New England Journal of Medicine.

As HemOnc Today previously reported, results showed osimertinib (Tagrisso, AstraZeneca) — a third-generation EGFR tyrosine kinase inhibitor — significantly prolonged PFS compared with erlotinib (Tarceva; Genentech, Astellas) or gefitinib (Iressa, AstraZeneca) among patients with previously untreated EGFR-positive NSCLC.

Investigators enrolled 556 patients from 29 countries.

Researchers randomly assigned patients to osimertinib 80 mg once daily or standard EGFR TKI therapy with erlotinib — dosed at 150 mg once daily — or gefitinib, dosed at 250 mg once daily.

Patients assigned osimertinib achieved significantly longer median PFS (18.9 months vs. 10.2 months; HR = 0.46; 95% CI, 0.37-0.57).

A similar proportion of patients in both groups achieved an objective response to treatment (80% vs. 76%; OR = 1.27; 95% CI, 0.85-1.9). However, median duration of response was 17.2 months (95% CI, 13.8-22) with osimertinib and 8.5 months (95% CI, 7.3-9.8) with standard EGFR TKIs.

OS data were only 25% mature at the time of the analysis. Eighty-three percent (95% CI, 78-87) of patients assigned osimertinib achieved 18-month OS compared with 71% (95% CI, 65-76) of patients assigned standard treatment (HR = 0.63; 95% CI, 0.45-0.88), but these data did not meet the P value of .0015 for statistical significance at interim analysis.

Fewer patients assigned osimertinib experienced grade 3 or worse adverse events (34% vs. 45%).

The most common adverse events included rash or acne (58% for osimertinib vs. 78% for standard EGFR TKI), diarrhea (58% vs. 57%) and dry skin (36% for both groups).

In September, the National Comprehensive Cancer Network updated its clinical practice guidelines to include the use of osimertinib for first-line treatment of patients with metastatic EGFR-mutated NSCLC, even though the agent is not approved by the FDA for this indication.

The FDA previously granted breakthrough therapy designation to osimertinib for first-line treatment of metastatic EGFR mutation-positive NSCLC.

Osimertinib is approved in the United States for the treatment of patients with EGFR T790M mutation-positive advanced NSCLC.