Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to dacomitinib 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.

This is written in the approval document as:

VIZIMPRO is a kinase inhibitor indicated 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.

Citation

Pfizer, Inc. Vizimpro (dacomitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211288s003lbl.pdf. Revised December 2020. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
FDA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Dacomitinib
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Dacomitinib