Pfizer Receives Positive CHMP Opinion for Vizimpro® (dacomitinib) for the First-line Treatment of Adult Patients with Locally Advanced Or Metastatic Non-Small Cell Lung Cancer with EGFR-Activating …

Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive op

Source: www.businesswire.com

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro 45 mg. Mono-therapy will 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 (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. The U.S. FDA approved Vizimpro in 2018, and was recently approved in Japan for EGFR gene mutation-positive, inoperable or recurrent NSCLC.