Pfizer’s Vizimpro (Dacomitinib) Receives the US FDA Approval for 1L Treatment of mNSCLC with Epidermal Growth Factor Receptor (EGFR)

Shots:

• The approval is based on P-III ARCHER 1050 study assessing Vizimpro 45mg vs Gefitinib 250mg in a ratio (1:1) in patients with unresectable, mNSCLC harboring EGFR, exon 19 deletion or exon 21 L858R substitution mutations, with no prior therapy for metastatic disease or recurrent disease with a minimum of 12 mos. disease-free after completion of systemic therapy
• P-III ARCHER 1050 Results: mPFS (14.7 mos. vs 9.2 mos.) as determined by Independent Radiologic Central (IRC) review. In 2012, Pfizer and SFJ Pharmaceuticals entered into a collaborative development agreement to conduct ARCHER 1050 across multiple sites
• Vizimpro recommended dose is 45 mg PO qd with/out food. Additionally, FDA granted Priority Review for Vizimpro for 1L treatment of patients with locally advanced or mNSCLC with EGFR-activating mutations

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