The European Commission (EC) has approved Pfizer’s drug Vizimpro (dacomitinib) as a monotherapy to treat adults with locally advanced or metastatic non-small cell lung cancer (NSCLC).

The approval allows use of the drug as a first-line therapy in patients with epidermal growth factor receptor (EGFR)-activating mutations.

Vizimpro is an oral, irreversible pan-human EGFR kinase inhibitor.

The drug’s regulatory approval is based on results from the Phase III ARCHER 1050 clinical trial performed in a total of 452 unresectable, metastatic or recurrent NSCLC patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

During the trial, 45mg Vizimpro was compared to 250mg gefitinib.

Primary endpoint of the randomised, multi-centre, multi-national, open-label study was progression-free survival (PFS). It also assessed secondary endpoints, including objective response rate (ORR), duration of response (DoR) and overall survival (OS).

“Vizimpro has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase III clinical trial.”

The trial met its primary endpoint with statistically significant improvement in PFS when treated with Vizimpro, compared to gefitinib.

Final analysis demonstrated an increase of 7.3 months in median OS in the Vizimpro arm.

Among 227 patients treated with Pfizer’s drug, 6.2% experienced serious adverse reactions. The most common serious adverse reactions were diarrhoea and interstitial lung disease.

Pfizer partnered with SFJ Pharmaceuticals in 2012 to conduct the trial at multiple clinical sites.

Pfizer Oncology International Developed Markets regional president Andreas Penk said: “The marketing authorization of Vizimpro, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase III clinical trial, provides a new option for patients with EGFR-mutated non-small cell lung cancer and reinforces Pfizer’s ongoing commitment to addressing the remaining needs of the thousands of EU patients with this disease.”

The drug also holds the US regulatory approval as first-line treatment for metastatic NSCLC patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

It also has Japanese and Canadian approvals for treating specific NSCLC patients.