By SPC News Staff
The FDA approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech).
The approval was based on two randomized trials, HannaH and SafeHER.
In HannaH, 596 patients with HER2-positive operable or locally advanced breast cancer, including inflammatory breast cancer, were randomly assigned to receive eight cycles of either trastuzumab/hyaluronidase-oysk or IV trastuzumab (Herceptin) concurrently with chemotherapy, followed by