Esteve Química (ESTEVE) a Spanish-based Contract Manufacturing Organization (CMO), announced it has been chosen by SEAGEN INC (SEAGEN) as one of the company's manufacturing partners in the global commercial supply chain of Tukysa® (tucatinib). ESTEVE is producing the Active Pharmaceutical Ingredient of Tukysa®, which has been approved by the Food and Drug Administration (FDA) in April of 20201, in its FDA-approved, cGMP, multipurpose facility in Spain. The two organizations are working to qualify the FDA-approved, cGMP, multipurpose site in Mexico for the manufacturing of tucatinib key starting materials. This distribution of the supply chain will provide more flexibility to support future product demands.
ESTEVE and SEAGEN have established a business collaboration several years back and have been working together on this program, which provides an option for metastatic HER2-positive breast cancer patients, including patients with brain metastases.
Tukysa® is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. It has been approved to treat metastatic HER2-positive breast cancer that has previously been treated with anti-HER2 regimens.
The two organizations are focused on improving health and meeting the needs of patients.