Dr. Pegram Discusses the Use of Neratinib in HER2+ Breast Cancer

Mark D. Pegram, MD
Published: Tuesday, May 22, 2018



Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses the use of neratinib (Nerlynx) in the treatment of patients with HER2-positive breast cancer.

The small molecule inhibitor neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of patients with early-stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin).

The significant challenge of treating patients with neratinib is managing the toxicities that often occur, Pegram says. However, some of the toxicities can be mitigated by concomitant medication with loperamide, as it can lower gastrointestinal toxicity. Now that it is approved by the FDA, Pegram says that the burden falls on the clinicians to make patients aware of the toxicity when considering it in a balanced discussion.

Pegram says that both neratinib and pertuzumab (Perjeta) will be restricted to higher-risk subsets of patients, and they do not need to be used in all patients as adjuvant treatment. It is important to consider whether the toxicity and expense merits the small efficacy signal that these agents provide, Pegram concludes.


Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses the use of neratinib (Nerlynx) in the treatment of patients with HER2-positive breast cancer.

The small molecule inhibitor neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of patients with early-stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin).

The significant challenge of treating patients with neratinib is managing the toxicities that often occur, Pegram says. However, some of the toxicities can be mitigated by concomitant medication with loperamide, as it can lower gastrointestinal toxicity. Now that it is approved by the FDA, Pegram says that the burden falls on the clinicians to make patients aware of the toxicity when considering it in a balanced discussion.

Pegram says that both neratinib and pertuzumab (Perjeta) will be restricted to higher-risk subsets of patients, and they do not need to be used in all patients as adjuvant treatment. It is important to consider whether the toxicity and expense merits the small efficacy signal that these agents provide, Pegram concludes.

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