Puma Biotechnology, Inc. (PBYI)

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Nerlynx is targeted against the HER1, HER2, and HER4 pathways and was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.

Nerlynx Improves Cancer-Free Survival in Early Breast Cancer
The targeted agent Nerlynx demonstrated an improvement in cancer-free survival when used after Herceptin® in early-stage, HER2-positive breast cancer.

Approximately 20-30% of breast cancer is referred to as human epidermal growth factor receptor-2 (HER2)-positive. This means that the breast cancer cells have too many HER2 proteins on their surface, which stimulates the cancer cells to grow and spread.

Agents targeting the HER2 proteins and HER2 pathway have been approved for the treatment of HER2-positive breast cancers. These agents reduce the excessive biochemical signaling that stimulates cancer growth and spread in HER2-positive cancers.

Herceptin is a commonly used agent in breast cancer that is targeted against HER2 proteins. It has demonstrated improvements in outcomes among patients with HER2-positive breast cancers, including early-stage breast cancers.

Neratinib is a novel agent referred to as a tyrosine kinase inhibitor that is targeted against several biochemical pathways implicated in the growth and spread of cancer. Specifically, Nerlynx is targeted against the HER1, HER2, and HER4 pathways.

The exteNET clinical trial, included 2,840 patients from 41 countries with HE2-positive early breast cancer who had received treatment with surgery, followed by treatment including Herceptin.

Following the completion of therapy with Herceptin, one group of patients in the trial received further treatment with Nerlynx, while the other group of patients received placebo (inactive substitute) for one year.

https://news.cancerconnect.com/breast-cancer/nerlynx-treatment-of-her2-positive-breast-cancer-GbvECmUxfkCQENpZZh_yNQ