Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that EGFR Exon 19 (Deletion) status confers therapeutic sensitivity to Dacomitinib in patients with Non-Small Cell Lung Cancer.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. Pfizer, Inc. Vizimpro (dacomitinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211288s000lbl.pdf. Revised September 2018. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-09-27	Food and Drug Administration	Indication received traditional approval.