European regulators have adopted a positive opinion recommending Pfizer’s Vizimpro for the first-line treatment of adult patients with locally advanced or metastatic non-smell cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.
The opinion of the Committee for Medicinal Products for Human Use (CHMP) will now be reviewed by the European Commission (EC).
Vizimpro (dacomitinib) was approved by the US 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.
“This positive CHMP opinion is an important step toward bringing this treatment to patients in Europe as a potential new first-line treatment option,” said Chris Boshoff, Chief Development Officer, Oncology, Pfizer Global Product Development.
“Vizimpro’s development is a direct result of Pfizer’s focus on precision drug development to create tailored options that improve patient outcomes.”
The Marketing Authorization Application for Vizimpro was based on results from ARCHER 1050, a randomised, multicentre, multinational, open-label, Phase 3 study.