US FDA approves tucatinib (in combination with trastuzumab and capecitabine) for adults with inoperable advanced HER2-positive breast cancer

Approval is based on HER2CLIMB trial (n=612) which showed progression-free survival (PFS) at 1yr was 33.1% in the tucatinib-combination group and 12.3% in the placebo-combination group (HR 0.54, 95% CI 0.42-0.71; P<0.001). Median duration of PFS was 7.8 v 5.6 months, respectively

SPS commentary:

A marketing authorisation application has also been filed with the European Medicines Agency.


Biospace Inc.