Home Alzheimer’s Disease FDA Approves Tucatinib in Combination with Chemotherapy for HER2-Positive Breast Cancer

FDA Approves Tucatinib in Combination with Chemotherapy for HER2-Positive Breast Cancer

The FDA approved tucatinib (Tukysa) in combination with chemotherapy (trastuzumab [Herzuma] and capecitabine [Xeloda]) for the treatment of adult patients with advanced forms of HER2-positive breast cancer that either cannot be removed with surgery or have spread to other parts of the body, including the brain, and who have received 1 or more prior treatments.

The FDA review of tucatinib was completed under Project Orbis in collaboration with the Australian Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA, Singapore) and Swissmedic (SMC, Switzerland). Though the FDA approved tucatinib, the application is still under review by other agencies. 

“The FDA’s Project Orbis provides a framework for concurrent submission and review of oncology drug applications among the FDA’s international collaborators,” said Richard Padzur, MD, director of the…

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