The FDA approves Roche (OTCQX:RHHBY -0.6%) unit Genentech’s subcutaneously administered Phesgo (pertuzumab, trastuzumab and hyaluronidase- zzxf) for adults with metastatic HER2-positive breast cancer and adults with early-stage HER2-positive breast cancer.
HER-positive tumors comprise ~20% of total breast cancer cases.
The company markets the intravenous (IV) formulation of pertuzumab as Perjeta and the IV formulation of trastuzumab as Herceptin.
Subcutaneous administration is enabled by the addition of hyaluronidase, branded as Enhanze by Halozyme Therapeutics (HALO +3.3%). Roche in-licensed the drug delivery technology in 2017.
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