FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

CHMP Gives Pfizer’s Lung Cancer Treatment Thumbs Up

Feb. 15, 2019

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended Pfizer’s Vizimpro (dacomitinib) as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations.

The drug is an epidermal growth factor receptor kinase inhibitor that was approved by the FDA in 2018 for patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

“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, Pfizer’s chief development officer for oncology.

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