Neratinib FDA Approval for Extended Adjuvant Therapy a Win for HER2+ Patients

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By Jame Abraham, MD

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The recent FDA approval of neratinib for extended adjuvant treatment of early-state, HER2-positive breast cancer is good news for many patients. I’ve been involved with the development of this therapy by being part of many clinical trials over the past seven years. Early studies in metastatic breast cancer have shown that neratinib is a very active HER2 blocker and has synergy with other HER2 targeted medicines such as trastuzumab. In addition, the most recent FDA approval is a testament of its efficacy in improving disease-free survival in high risk HER2-positive patients after one year of trastuzumab.

Neratinib is an irreversible tyrosine kinase inhibitor (TKI) that interrupts signaling across the ErbB family by inhibiting phosphorylation and activity of HER2, in addition to epidermal growth factor, HER1 and HER4. We recently showed neratinib’s promise in a combination therapy trial with trastuzumab ematansine (T-DM1). The results I presented at the 2017 American Association for Cancer Research meeting showed an objective response rate of 56 percent in patients with advanced, HER2-positive breast cancer and resistance to trastuzumab and pertuzumab. We are expanding this study into more centers and enrolling more patients in a phase 2 study (NSABP FB 10).

The overall role of neratinib in the management of breast cancer is evolving.  I think the FDA’s approval for extended adjuvant treatment is a positive indication that this drug will be an important part of the treatment landscape for many years to come.

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Dr. Abraham is Director of the Breast Oncology Program at Cleveland Clinic Cancer Center.