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Vizimpro FDA Approval History

FDA Approved: Yes (First approved September 27, 2018)
Brand name: Vizimpro
Generic name: dacomitinib
Dosage form: Tablets
Company: Pfizer Inc.
Treatment for: Non-Small Cell Lung Cancer

Vizimpro (dacomitinib) is an oral, once-daily, irreversible pan-human epidermal growth factor receptor tyrosine kinase inhibitor (TKI) indicated for the treatment of 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.

Development timeline for Vizimpro

Sep 27, 2018Approval FDA Approves Vizimpro (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer
Jun  4, 2018Dacomitinib Shows More than Seven-Month Improvement in Overall Survival Compared to an Established Therapy in Advanced NSCLC with EGFR-Activating Mutations
Apr  4, 2018U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations

Further information

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