Neratinib First Extended Adjuvant Treatment for Patients with Early-Stage, HER2-Positive Breast Cancer

Web Exclusives - FDA Approvals

On July 17, 2017, the FDA approved neratinib (Ner­lynx; Puma Biotechnology) for the long-term, adjuvant treatment of adults with early-stage, HER2-positive breast cancer who have received therapy that includes trastuzumab. Neratinib, a kinase inhibitor that blocks several cell-growth–promoting enzymes, is taken after treatment to lower the risk for cancer recurrence.

“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 neratinib was based on the safety and efficacy results of a randomized clinical trial of 2840 patients with early-stage, HER2-positive breast cancer who had completed trastuzumab therapy in the past 2 years. Efficacy measures included the time to disease relapse or death from any cause. At 2 years, 94.2% of patients who received ner­atinib were alive and with no cancer recurrence versus 91.9% of patients who received placebo.

The common adverse events associated with neratinib include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, liver damage, nail disorder, dry skin, distention, weight loss, and urinary tract infection.

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Last modified: August 10, 2017
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