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NICE approves dacomitinib for NSCLC

NICE has approved dacomitinib as a therapeutic option for untreated locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) in adults.

The main clinical evidence considered by the NICE appraisal came from the multicentre, open-label, phase 3 randomised controlled ARCHER 1050 trial, which compared the efficacy and safety of dacomitinib (n=227) with gefitinib (n=225) in untreated locally advanced or metastatic EGFR mutation-positive NSCLC. Patients had either the exon 19 deletion (del19) or exon 21 (L858R) EGFR mutation. The trial included 71 study sites in seven countries.

ARCHER 1050 found that dacomitinib statistically significantly improved progression-free survival (PFS) compared with gefitinib (14.7 months for dacomitinib compared with 9.2 months for gefitinib; hazard ratio [HR] 0.589; 95% CI 0.47-0.74). Exploratory analyses also showed that dacomitinib improved overall survival (OS) compared with gefitinib (34.1 months for dacomitinib compared with 26.8 months for gefitinib; HR 0.760; 95% CI 0.58-0.99). However, NICE commented on the uncertainty around how subsequent treatments may have affected the OS estimates in ARCHER 1050.

Dacomitinib was associated with substantially more adverse events and may require more dose reductions than gefitinib.

Although there was some uncertainty about the assumptions used in the cost-effectiveness modelling, NICE concluded that the most plausible cost-effectiveness estimate was within what NICE normally considers an acceptable use of NHS resources.

Dacomitinib is administered orally at a dose of 45 mg once daily, until disease progression or unacceptable toxicity. 


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