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Poziotinib is an investigational drug not approved by the FDA.
Introduction
This study is for the treatment for EGFR or HER2 Exon 20 insertion Mutation-Positive Non-Small Cell Lung Cancer. Poziotinib is a new type of treatment and is considered investigational. “Investigational” means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) because we do not know enough about the benefits or side effects of poziotinib in the treatment for EGFR or HER2 Exon 20 Insertion Mutation-Positive Non-Small Cell Lung Cancer.
The surface of lung cells contain some proteins called the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2). These proteins play an important part in the cell growth and survival. When the proteins of these cells genetically change or have gene mutations, these and other changes can cause cancer or control the growth of cancer. Once such mutations have been identified by tests that look at your cancer or blood samples from a molecular level, it is believed that this study’s treatment with poziotinib may “target” these mutations and may stop the growth of this certain type of cancer.
What is poziotinib?
Poziotinib, the “study” drug, is a tyrosine kinase inhibitor (TKI) and is one of the new group of treatments called “targeted therapies”. Targeted therapies are designed to slow or stop certain types of cancer cells by targeting specific changed or mutated molecules that help cancer cells grow or spread. Poziotinib is given by mouth in the form of a tablet. Poziotinib has been studied in over 200 patients with advanced cancers to date.
The more commonly experienced side effects with TKIs include skin rash, diarrhea and mucositis.
These side effects can be managed with the help of your study team. In addition, occurrence of these side effects with TKI drugs, such as rash have been shown to serve as signs that these products may have an effect on the targets.
