NICE rejects Tagrisso in first-line non-small cell lung cancer - AstraZeneca

In final draft guidance, the National Institute for Health and Care Excellence (NICE) has rejected Tagrisso, because the survival benefits compared with standard treatment such as Iressa (gefitinib) are unclear in first-line non-small cell lung cancer. NICE considered results from the FLAURA trial, comparing Tagrisso with Tarceva (erlotinib) and Iressa (gefitinib) in untreated patients. Patients in the trial had either exon 19 deletion (del19) or exon 21 (L858R) mutations, accounting for around 90% of EGFR mutations. NICE said it noted progression-free survival was 18.9 months on Tagrisso compared with 10.2 months on standard care. Overall survival data is not mature but data gathered so far show that Tagrisso will likely extend this. However NICE is concerned that data so far do not show the size of treatment benefits, and that its economic model does not fully exceed the benefits of subsequent treatments. AstraZeneca will appeal the NICE decision to reject Tagrisso. The indication was for untreated locally advances or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in adults,