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FDA Accepts BLA for Subcutaneous Fixed-Dose Pertuzumab/Trastuzumab in HER2+ Breast Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Feb 25, 2020

The FDA has accepted a Biologics License Application (BLA) for a fixed-dose combination (FDC) of pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.1

The BLA is based on data from the phase III FeDeriCa study, in which an SC FDC of pertuzumab and trastuzumab demonstrated noninferiority to intravenous formulations of the 2 drugs with respect to pharmacokinetics, clinical activity, and safety.2

The 500-patient study met the primary end point, demonstrating noninferiority on the basis of predose cycle 8 serum Ctrough for the pertuzumab component of the FDC, with a mean value of 93.7 versus 78.5 µg/mL for IV pertuzumab. Geometric means were 88.7 and 72.4 µg/mL, respectively (geometric mean ratio [GMR], 1.22; 90% CI, 1.14-1.31).

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