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FDA Approves Neratinib Combo for HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Wednesday, Feb 26, 2020

The FDA has approved a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.1

The objective responsive rate was 32.8% (95% CI, 27.1-38.9) for the neratinib arm and 26.7% (95% CI, 21.5-32.4) for the lapatinib arm, respectively. The median duration of response was 8.5 months (95% CI, 5.6-11.2) versus 5.6 months (95% CI, 4.2-6.4), respectively.


Fewer patients required intervention for CNS metastases with neratinib versus lapatinib. At 54 months, the cumulative incidence for intervention for CNS metastases was 22.8% versus 29.2% for the neratinib and capecitabine arms, respectively (P = .043).

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