FDA approves first new drug under Project Orbis

The US Food and Drug Administration (FDA) on Friday approved the first new molecular entity as part of an international collaborative review effort dubbed Project Orbis.

The drug, Seattle Genetics’ Tukysa (tucatinib) was approved in combination with chemotherapy drugs trastuzumab and capecitabine to treat adult patients with inoperable or metastasized advanced HER2-positive breast cancer who have received prior treatments.