FDA accepts BLA for fixed-dose combination of Perjeta + Herceptin with hyaluronidase, by subcutaneous injection in combination with I.V. chemotherapy for the treatment of HER2-positive breast cancer. Genentech/Roche

Genentech, a member of the Roche Group announced that the FDA has accepted the company’s Biologics License Application (BLA) for the fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer. The BLA for the FDC is based on results from the Phase III FeDeriCa study, which demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy. The FDA is expected to decide on approval by October 18, 2020. SC administration of the FDC takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines..