image credit: The U.S. FDA / Wikimedia

FDA approves Roche s Phesgo, a Fixed-Dose Combination Breast Cancer Drug

July 1, 2020


On June 29, 2020, FDA approved Phesgo, a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC) injection. The product was approved for use in combination with intravenous (IV) chemotherapy for treating early and metastatic HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test, according to an FDA press release. The agency granted the approval to Genentech, a Roche company.

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