FDA accepts Roche ’s Biologics License Application for fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast cancer
Basel, 25 February 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (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 subc utaneous (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 (pharmacokinet ics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy.1“For more than two decades, our medicines have redefined the standard of care for people with HER2-positive breast cancer,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s acceptance builds upon our commitment by potentially o ffering patients a faster way to administer Perjeta and Herceptin. We’re working with the FDA to bring this treatment option to patients as quickly as possible.” SC administration of the FDC takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.1 This is compared to approximately 150 minutes for infusion of a loading dose of Perjeta and He...
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