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Roche : CHMP Recommends EU Approval Of Phesgo For HER2-positive Breast Cancer

Roche (RHHBY) said Friday that the European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.

The recommendation is based on results from the pivotal phase III FeDeriCa study, which showed that treatment with Phesgo produced non-inferior levels of Perjeta and Herceptin in the blood when compared to IV administration of the two medicines.

Phesgo is a fixed-dose combination of Perjeta or pertuzumab and Herceptin or trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy.

The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer.

The Herceptin SC vial is approved for the treatment of HER2-positive breast cancer in more than 100 countries worldwide.

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