EC Approves Pfizer’s VIZIMPRO as Monotherapy for Advanced Non-Small Cell Lung Cancer

April 17, 2019

EC has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with advanced or non-small cell lung cancer (NSCLC).

The European Commission (EC) has granted approval of Pfizer’s VIZIMPRO (dacomitinib) as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

This marketing authorization approval decision was supported with data from a randomized, multicentre, multinational, open-label, Phase III study (ARCHER 1050), which demonstrated a statistically significant improvement of progression-free survival of VIZIMPRO-treated patients compared with gefitinib-treated patients.

“Lung cancer remains the leading cause of cancer-related death worldwide, and despite advances in biomarker-driven therapies, overcoming resistance continues to be crucial in treating EGFR-mutated non-small cell lung cancer,” said Andreas Penk, regional president, Oncology International Developed Markets at Pfizer, in an April 3, 2019 press release. “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 European Union patients with this disease.”

“Over the last two decades, biomarker-driven therapies have become standard-of-care for patients with EGFR-mutated non-small cell lung cancer,” said Federico Cappuzzo, director of Oncology and Hematology Department AUSL della Romagna-Ravenna. “The improvement in progression-free survival for VIZIMPRO over a first-generation standard-of-care therapy in the ARCHER 1050 study is impressive, and I’m pleased it will be available for appropriate patients with non-small cell lung cancer in the EU.”

Source: Pfizer