FDAnews Drug Daily Bulletin

FDA Approves Puma’s Neratinib for HER2 Breast Cancer

July 21, 2017

The FDA approved Puma Biotechnology’s Nerlynx (neratinib) for extended treatment of early-stage HER2-overexpressed breast cancer following a Herceptin-based therapy.

Approval was based on a Phase III randomized trial of Nerlynx following adjuvant Herceptin  treatment.

The trial in more than 2,800 patients found treated patients had a rate of invasive disease-free survival of 94.2 percent after two years, compared to 91.9 percent with placebo.

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