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

 Ref: Pfizer | Image: The Times