FDA Approves Phesgo as Injection Treatment for HER2-positive Breast Cancers

FDA Approves Phesgo as Injection Treatment for HER2-positive Breast Cancers
The U.S. Food and Drug Administration (FDA) has approved Phesgo, an under-the-skin injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, as a faster and more convenient alternative to treat people with HER2-positive breast cancer. The approval of this fixed-dose combination is for use with chemotherapy in early and metastatic breast cancers, the same indications for which the combination of intravenous (into-the-vein) Herceptin and Perjeta is approved. The original formulations required intravenous infusions given over 2.5 hours. Phesgo was developed by Genentech as an equally effective and safe option, given to patients by a healthcare provider as an injection into the thigh that takes less than 10 minutes. This subcutaneous injection can be administered at a treatment center or a patient's home. “Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in an agency press release. "At this critical time, we continue to expedite oncology product development," Pazdur added. "This application was approved about four months ahead of the FDA goal date,” which was set for Oct. 18. Herceptin and Perjeta, both developed by Genentech, are inhibitors of the HER2 receptor, a protein known to participate in breast cancer growth and survival, with distinct mechanisms of action. Perjeta works to prevent the HER2 protein from binding to the HER3 protein, and Hercepti
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