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Breast CancerFDA Approvals, News & UpdatesNewsworthy

Neratinib First Long-Term Adjuvant Therapy for Early-Stage, HER2-Positive Breast Cancer

On July 17, 2017, the FDA approved Nerlynx (neratinib; from Puma Biotechnology) for long-term adjuvant treatment of early-stage, HER2-positive breast cancer in patients who received previous therapy with Herceptin (trastuzumab).
December 2017 Vol 3 No 6

On July 17, 2017, the FDA approved Nerlynx (neratinib; from Puma Biotechnology) for long-term adjuvant treatment of early-stage, HER2-positive breast cancer in patients who received previous therapy with Herceptin (trastuzumab). Nerlynx, a kinase inhibitor that blocks enzymes that promote cell growth (including cancer cells), is taken after breast cancer treatment to reduce the risk of the cancer coming back.

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan. Now, these patients have an option after initial treatment that may help keep the cancer from coming back,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

The approval of Nerlynx was based on a clinical trial of patients who had completed Herceptin therapy in the past 2 years. After 2 years, 94% of patients who used Nerlynx were alive and their cancer did not come back compared with 92% of patients who received a placebo.

The most common side effects of Nerlynx include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, muscle spasms, dyspepsia, liver damage, nail and skin disorders, weight loss, and urinary tract infection.

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Last modified: February 28, 2018

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