FDA approves Pfizer’s Vizimpro for non-small cell lung cancer

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FDA approves Pfizer’s Vizimpro for non-small cell lung cancer

By Sandra Levy - 10/10/2018
Pfizer has received the green light from the Food and Drug Administration (FDA) for Vizimpro (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,” Pfizer oncology global president Andy Schmeltz said, in a press statement. “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.”

“EGFR-mutated advanced non-small cell lung cancer is a common illness, especially in the Asian population, and new treatment options will ultimately benefit patients,” primary investigator for the ARCHER 1050 study and chair of the department of clinical oncology, The Chinese University of Hong Kong Tony Mok said, in a statement. “The findings from ARCHER 1050 suggest that Vizimpro should be considered as a new first-line treatment option for patients with EGFR-mutated non-small cell lung cancer exon 19 deletion or exon 21 L858R substitution mutations.”

"Today’s approval of Vizimpro is a direct result of our commitment to precision drug development and improving outcomes for patients with mutation-driven lung cancers. Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer: Xalkori for patients with ALK-positive or ROS1-positive non-small cell lung cancer and Vizimpro for patients with EGFR-mutated non-small cell lung cancer,” Pfizer global product development, chief development officer oncology Mace Rothenberg said, in a statement.

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