The FDA approved trastuzumab and hyaluronidase-oysk injection for subcutaneous use (Herceptin Hylecta, Genentech) for the treatment of HER2 overexpressing breast cancer.
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