The Food and Drug Administration (FDA) has approved neratinib (Nerlynx; Puma Biotechnology), a kinase inhibitor, in combination with capecitabine, a nucleoside metabolic inhibitor, for the treatment of adult patients with advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received 2 or more prior anti-HER2 based regimens in the metastatic setting.

The approval was based on data from a phase 3, an open-label, active-controlled study comparing the combination of neratinib plus capecitabine vs lapatinib plus capecitabine in patients with metastatic HER2-positive breast cancer who had received 2 or more prior anti-HER2 based regimens in the metastatic setting (N=621). The co-primary end points of the study were progression free survival (PFS) and overall survival (OS).

Results showed a statistically significant improvement in PFS with neratinib plus capecitabine compared with lapatinib plus capecitabine (hazard ratio [HR] 0.76; 95% CI, 0.63-0.93; P =.0059); PFS rates at 12 months and 24 months were 29% (95% CI, 23-35) and 12% (95% CI, 7-18) for the neratinib plus capecitabine arm, respectively vs 15% (95% CI, 10-20) and 3% (95% CI, 1-8) for lapatinib plus capecitabine.

For patients who received neratinib plus capecitabine, median OS was 21 months (95% CI, 17.7-23.8) compared with 18.7 months (95% CI, 15.5-21.2) for those who received lapatinib plus capecitabine (HR 0.88; 95% CI, 0.72-1.07; P =.2086).

With regard to safety, the most common adverse reactions associated with neratinib plus capecitabine were diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms; diarrhea, nausea, vomiting, fatigue and decreased appetite were the most frequently reported grade 3 or 4 adverse reactions.

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“This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to Nerlynx’s established role in the treatment of early breast cancer,” said Adam M. Brufsky, MD, PhD, of Magee-Womens Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center.

Neratinib is also indicated for use as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab based therapy.

For more information visit nerlynx.com.