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European approval for Pfizer's Vizimpro in first-line non-small cell lung cancer

Published on 04/04/19 at 09:54am

The European Commission has awarded marketing approval to Pfizer’s tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib), it has emerged, as a first-line monotherapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Data derived from a Phase 3 study examining the drugs’ use in 227 patients with EGFR-mutated metastatic NSCLC showed a “statistically significant improvement” in progression-free survival, as determined by Independent Radiologic Central (IRC) review, meeting the primary endpoint.

Additionally, Vizimpro improved median overall survival by 7.3 months compared to AstraZeneca and Teva’s Iressa (gefitinib), with each scoring 34.1 months and 26.8 months respectively.  

“Over the last two decades, biomarker-driven therapies have become standard-of-care for patients with EGFR-mutated non-small cell lung cancer,” said Dr 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.”

Dr Andreas Penk, Regional President, Oncology International Developed Markets at Pfizer, added: “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. The marketing authorisation of Vizimpro, which has shown a more than five-month improvement in progression-free survival over an existing therapy in a Phase 3 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.”

Matt Fellows

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