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

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

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

Click here to read full press releasearticle | Ref: Pfizer | Image: The Times

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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