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Dacomitinib: First Global Approval.

¹Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

|December 4, 2018

Summary

This summary is machine-generated.

Dacomitinib is a new treatment for metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations. It has received FDA approval for first-line treatment, marking a significant milestone.

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Area of Science:

Oncology
Pharmacology
Molecular Biology

Background:

Dacomitinib (Vizimpro®) is an orally administered small-molecule irreversible inhibitor targeting HER1 (EGFR), HER2, and HER4.
Developed by Pfizer Inc., it is indicated for the treatment of solid tumors.

Purpose of the Study:

To summarize the development milestones of dacomitinib.
To highlight the drug's first approval for first-line treatment of EGFR-mutated metastatic non-small cell lung cancer (NSCLC).

Main Methods:

Review of dacomitinib's development history and clinical trial data.
Analysis of regulatory submission and approval processes.

Main Results:

Dacomitinib received its first global approval in the USA in September 2018.

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Approval is for the first-line treatment of metastatic NSCLC patients with EGFR exon 19 deletion or exon 21 L858R substitution mutations.

Registration applications are also submitted in the EU and Japan.

Conclusions:

Dacomitinib's approval represents a significant advancement in the first-line treatment of EGFR-mutated metastatic NSCLC.
The drug's development journey culminated in this important regulatory milestone.