New Formulation of Roche’s Perjeta-Herceptin Combo for HER2-Positive Breast Cancer Up for Possible FDA Approval

New Formulation of Roche’s Perjeta-Herceptin Combo for HER2-Positive Breast Cancer Up for Possible FDA Approval
The U.S. Food and Drug Administration (FDA) will review Roche’s application seeking regulatory approval for a new formulation — given as a subcutaneous, or under-the-skin injection — of the fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating people with HER2-positive breast cancer. This new formulation takes just minutes to administer, as compared with the 2.5 hours needed for the current treatment, given intravenously (into the vein), Roche said. If approved, the new formulation will help reduce the dosing time for patients receiving the combo treatment, which will be given together with intravenous, or IV chemotherapy. The enzyme hyaluronidase also will be given together with the combination to assist in its delivery. The FDA is expected to decide on the therapy's approval by Oct. 18, Roche said. “For more than two decades, our medicines have redefined the standard of care for people with HER2-positive breast cancer,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in a press release. “Today’s acceptance builds upon our commitment by potentially offering patients a faster way to administer Perjeta and Herceptin. We
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