November 13, 2020 -- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's Phesgo, a fixed-dose combination of the monoclonal antibodies (mAbs) pertuzumab (Perjeta) and trastuzumab (Herceptin) with hyaluronidase.
The dose is to be administered by subcutaneous injection along with IV chemotherapy for the treatment of early and metastatic HER2-positive breast cancer. The administration takes approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. The standard IV formulations take approximately 150 minutes for infusion of a loading dose of Perjeta and Herceptin and between 60-150 minutes for subsequent maintenance infusions of the two medicines.
The CHMP's recommendation stems from the phase III FeDeriCa study, which showed treatment with Phesgo produced noninferior levels of Perjeta and Herceptin in the blood when compared with IV administration.
Based on the recommendation, a final decision regarding Phesgo's approval is expected from the European Commission in the near future, Roche said.
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