The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Seagen’s Tukysa in combination with trastuzumab and capecitabine for the treatment of advanced HER2-positive breast cancer.
Specifically, the MHRA has authorised the Tukysa combination for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have previously been treated with at least two prior anti-HER2 treatment regimens.
The authorisation is based on results from Seagen’s HER2CLIMB trial, that enrolled 612 patients with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received – separately or in combination – trastuzumab, pertuzumab and ado-trastuzumab emtansine (T-DM1).
Results from this trial showed patients who were treated with Tukysa in combination with trastuzumab and capecitabine had a 46% reduction in the risk of cancer progression or death – progression free survival (PFS).
The addition of Tukysa also reduced the risk of death by 34%, with a median overall survival (OS) of 21.9 months for the Tukysa group compared to 17.4 months for placebo.
“The Tukysa combination is a landmark therapy for patients with HER2-positive metastatic breast cancer with or without brain metastases, extending overall survival in these patients after two prior anti-HER2-treatment regimens,” said Clay Siegall, chief executive officer at Seagen.
“We are pleased Tukysa is now authorised in the UK, and we look forward to further collaborating with the national reimbursement bodies to ensure it is available to adult patients,” he added.