European regulator to review tucatinib combo therapy in breast cancer

31 January 2020

The European Medicines Agency (EMA) is to review a marketing authorization application from Seattle Genetics (Nasdaq: SGEN) for a tucatinib combination therapy in breast cancer.

The firm wants to offer the tyrosine kinase inhibitor (TKI) in combination with trastuzumab, which is marketed by Roche (ROG: SIX) as Herceptin, and the chemotherapy capecitabine.

The application, which is supported by data from the HER2CLIMB trial, relates to people with locally-advanced unresectable or metastatic HER2-positive breast cancer who have had at least two anti-HER2 treatment regimens.

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