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VIZIMPRO FDA Approval Press Release ED

U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

Approval Supported by Data from Phase 3 Head-to-Head Study vs. Gefitinib

NEW YORK, N.Y., September 27 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

“Improving outcomes for patients is the central focus of why we develop and deliver new medicines. VIZIMPRO is yet another example of Pfizer’s commitment to providing more options in lung cancer where there is great unmet need,” said Andy Schmeltz, Global President, Pfizer Oncology. “With today’s approval, Pfizer has medicines that target three unique lung cancer biomarkers, marking real progress for patients which has been achieved through a diverse and persistent drug development approach.”

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