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Halozyme Announces CHMP Recommends EU Approval Of Roche's Phesgo® (Fixed-Dose Combination Of Perjeta® And Herceptin® For Subcutaneous Injection) Utilizing Halozyme's ENHANZE® Technology For HER2-Positive Breast Cancer
- Phesgo® Can be Administered in 5 to 8 Minutes Compared with 1-2.5 Hours for the Standard Sequential IV Administration of Perjeta® and Herceptin®[1,2,3] - -
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- Phesgo® Can be Administered in 5 to 8 Minutes Compared with 1-2.5 Hours for the Standard Sequential IV Administration of Perjeta® and Herceptin®[1,2,3] -\n - Phesgo® is the First Subcutaneous Fixed-dose Combination of Two Monoclonal Antibodies Utilizing Halozyme's ENHANZE® Technology -\n\n\nSAN DIEGO, Nov. 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that 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 Perjeta® (pertuzumab) and Herceptin® (trastuzumab) utilizing ENHANZE®, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future. \n\"We are delighted that Phesgo®, the first combination of two established monoclonal antibodies with our ENHANZE® technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU,\" said Dr. Helen Torley, president and chief executive officer.\nPhesgo® can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose1. This is compared to approximately 150 minutes for a sequential 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 medicines2,3. \nThe recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo® showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta®. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia1,4.\nThe U.S. Food and Drug Administration recently expedited the approval of Ph...