Pfizer’s Vizimpro receives EMA approval recommendation for NSCLC treatment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a significant boost to Pfizer‘s lung cancer drug, Vizimpro (dacomitinib), recommending its approval as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This recommendation specifically targets patients with epidermal growth factor receptor (EGFR)-activating mutations, a condition that is often difficult to treat and associated with poor overall survival rates.

Vizimpro’s journey to approval in Europe is bolstered by its success in multiple markets. Last year, the drug received approval in the United States for the first-line treatment of patients with metastatic NSCLC harbouring EGFR exon 19 deletion or exon 21 L858R substitution mutations. Additionally, Pfizer’s treatment has gained approval in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.

The positive CHMP opinion comes after a rigorous evaluation of the drug’s effectiveness in the phase 3 ARCHER 1050 clinical trial. Involving 452 patients with advanced or metastatic NSCLC, the study compared Vizimpro’s efficacy against gefitinib 250 mg. The trial primarily focused on patients who had not received prior treatment for metastatic disease or recurrent disease following at least 12 months of disease-free status after systemic therapy.

Chris Boshoff, Pfizer’s Chief Development Officer for Oncology, commented on the EMA committee’s decision, highlighting the importance of this step in bringing Vizimpro to patients in Europe. He emphasized the drug’s role in addressing the need for more treatment options for those suffering from EGFR-mutated NSCLC, a form of cancer that typically presents a grim prognosis. Boshoff also underscored Pfizer’s commitment to precision drug development aimed at improving patient outcomes with tailored treatments.

Vizimpro is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor, marking it as a potential game-changer in the treatment landscape for EGFR-mutated NSCLC.