On November 13, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported 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 (Press release, Halozyme, NOV 13, 2020, View Source [SID1234570914]). Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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.
Phesgo 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.
The 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.
The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient’s home.
About ENHANZE Technology
Halozyme’s proprietary ENHANZE drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.