Posted by Michael Wonder on 25 Feb 2020
FDA accepts Genentech’s biologics license application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
24 February 2020 - Fixed-dose combination is administered under the skin in just minutes, compared to hours with intravenous administration, significantly reducing time spent receiving treatment.
Genentech today announced that the U.S. FDA has accepted the company’s biologics license application 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 application 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.
