Roche | MEDIA
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CHMP recommends EU label update for Roche’s Phesgo to allow administration outside of clinical settings
The European Medicines Agency recommends approving at-home administration of Roche's Phesgo for HER2-positive breast cancer. This follows positive clinical, real-world, and bioequivalence data demonstrating feasibility and safety. Patient preference strongly supports at-home treatment, reducing healthcare system burdens and improving quality of life. Cost savings of up to 80% are projected in Western Europe by switching to Phesgo. The CHMP's positive opinion is based on various studies showing no new safety concerns with at-home administration by healthcare professionals. Phesgo is already approved in over 120 countries as a subcutaneous alternative to intravenous treatment. The drug significantly improves treatment outcomes compared to standard therapies. Roche's long-term research in HER2-positive breast cancer has led to improved survival rates and significant economic benefits. A final decision from the European Commission is pending. This at-home option aims to alleviate the socioeconomic burden of HER2-positive breast cancer.