FDA Approves Dacomitinib for Metastatic NSCLC

It is approved for first-line treatment of patients with tumours with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test
02 Oct 2018

On 27 September 2018, the US Food and Drug Administration (FDA) approved dacomitinib tablets (VIZIMPRO, Pfizer Pharmaceutical Company) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. 

Approval was based on a randomised, multicentre, open-label, active controlled trial (ARCHER 1050; NCT01774721) comparing the safety and efficacy of dacomitinib to gefitinib in 452 patients with unresectable, metastatic NSCLC. Patients were required to have no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free interval after completion of systemic non-EGFR-TKI-containing therapy; an Eastern Cooperative Oncology Group performance status of 0 or 1; and EGFR exon 19 deletion or exon 21 L858R substitution mutations. Patients were randomised (1:1) to receive either dacomitinib 45 mg orally once daily or gefitinib 250 mg orally once daily until disease progression or unacceptable toxicity. 

The trial demonstrated a significant improvement in progression-free survival (PFS); no improvement in overall response rate or overall survival were demonstrated. The median PFS, as determined by an independent review committee was 14.7 and 9.2 months in the dacomitinib and gefitinib arms, respectively (hazard ratio 0.59; 95% CI: 0.47, 0.74; p<0.0001). 

The prescribing information contains warnings and precautions for interstitial lung disease (ILD), diarrhoea, and dermatologic adverse reactions. Of 394 patients who received dacomitinib, serious adverse reactions occurred in 27%. The most common adverse reactions resulting in discontinuation in of dacomitinib were diarrhoea and ILD. The most common (>20%) adverse reactions of dacomitinib were diarrhoea, rash, paronychia, stomatitis, decreased appetite, dry skin, decreased weight, alopecia, cough, and pruritus. 

The recommended dacomitinib dose is 45 mg orally once daily with or without food. 

Full prescribing information for VIZIMPRO is available here.

FDA granted this application priority review and orphan drug designation. 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

Last update: 02 Oct 2018

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