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The fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase was approved for medical use in the United States in June 2020. [5] [10]The FDA's approval was based on the results of a non-inferiority study in participants with HER2-positive early breast cancer, which demonstrated the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase had comparable efficacy and ...
"Trastuzumab". Drug Information Portal. U.S. National Library of Medicine. "Hyaluronidase". Drug Information Portal. U.S. National Library of Medicine. "Trastuzumab and Hyaluronidase-oysk". National Cancer Institute. 14 March 2019. "Trastuzumab and Hyaluronidase-oysk". NCI Drug Dictionary. National Cancer Institute.
Other severe side effects include heart failure, allergic reactions, and lung disease. [31] Use during pregnancy may harm the baby. [23] Trastuzumab works by binding to the HER2 receptor and slowing down cell replication. [31] Trastuzumab was approved for medical use in the United States in September 1998, and in the European Union in August 2000.
Pertuzumab is administered as an intravenous infusion in combination with trastuzumab and docetaxel as a first line treatment for HER2-positive metastatic breast cancer. [4] [3] It is also used in the same combination as a neoadjuvant (given to reduce the size of a tumor, prior to surgery or radiation) for HER2-positive early breast cancer; as of 2016 this use had not been shown to increase ...
The safety and effectiveness of trastuzumab emtansine were evaluated in a clinical study of 991 patients randomly assigned to receive trastuzumab emtansine or lapatinib plus capecitabine, another chemotherapy drug. [18] Patients received treatment until either the cancer progressed or the side effects became intolerable. [18]
Participants were randomized 1:1 to receive either trastuzumab deruxtecan or trastuzumab emtansine by intravenous infusion every three weeks until unacceptable toxicity or disease progression. [16] Randomization was stratified by hormone receptor status, prior treatment with pertuzumab, and history of visceral disease. [16]
The primary test for efficacy measured the forced vital capacity, or FVC, which is a measure of lung function, defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. [38] Those who took nintedanib had less lung function decline compared to those on placebo. [38]
Elevated tissue expression of hyaluronic acid and hyaluronidase validates the hyaluronic acid-hyaluronidases urine test for bladder cancer. [48] Limited data support a role of lysosomal hyaluronidases in metastasis, while other data support a role in tumor suppression. Other studies suggest no contribution or effects independent of enzyme activity.