The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending Vizimpro (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations. The CHMP’s opinion will now be reviewed by the European Commission
The agent is sponsored by Pfizer.
Vizimpro was approved by FDA in 2018 for the first-line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. It was also recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.
The Marketing Authorization Application for Vizimpro was based on results from ARCHER 1050, a randomized, multicenter, multinational, open-label, phase III study conducted in patients with locally advanced unresectable, or metastatic NSCLC harboring EGFR exon 19 deletion or exon 21 L858R substitution mutations, an Eastern Cooperative Oncology Group performance status of 0 or 1; with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy. A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225).
Vizimpro is an oral, once-daily, irreversible pan-human epidermal growth factor receptor kinase inhibitor for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor-activating mutations.
Vizimpro is approved in the U.S. for the first-line treatment of patients with metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Vizimpro is also approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC. The applications in the US and Japan were reviewed and approved under the Priority Review program.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites. SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. Under the terms of this agreement, SFJ Pharmaceuticals provided the funding and conducted the trial to generate the clinical data used to support this application. Pfizer retains all rights to commercialize Vizimpro globally.
The efficacy of Vizimpro was demonstrated in ARCHER 1050, a global phase III head-to-head trial conducted in patients with locally advanced unresectable, or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 months disease-free after completion of systemic therapy.
A total of 452 patients were randomized 1:1 to Vizimpro 45 mg (n=227) or gefitinib 250 mg (n=225). Randomization was stratified by region and EGFR mutation status. The primary endpoint of the study was progression-free survival as determined by blinded Independent Radiology Central review. Key secondary endpoints included objective response rate, duration of response, overall survival, and patient-reported outcomes.
