Just a week after posting strong data at the San Antonio Breast Cancer Symposium, Seattle Genetics has nabbed the coveted FDA breakthrough label for its oncology hopeful.
At the conference, Seattle Genetics shared more of the tucatinib data it hopes will win it approval in HER2-positive breast cancer. The pivotal trial linked the tyrosine kinase inhibitor to reduced risk of progression and death in patients with and without brain metastases, leading Seattle Genetics CEO Clay Siegall to hail the data as “stunning.”
Investigators enrolled 612 women with locally advanced or metastatic HER2-positive breast cancer who had on average received four lines of prior therapy. The patients, close to half of whom had brain metastases, were no longer responding to Roche’s HER2 drugs Herceptin, Perjeta or Kadcyla.
In that hard-to-treat population, adding tucatinib to Herceptin and capecitabine was associated with a 46% reduction in the risk of disease progression or death over the backbone regimen alone. In the subgroup of patients with brain metastases, the reduction in risk of disease progression or death was bigger still at 52%. Seattle Genetics is happy with the results.
And now it’s even happier with the FDA tag, which in essence can speed up the regulator’s review process and potentially get the med approved faster.
“The addition of tucatinib to the commonly used combination of trastuzumab and capecitabine demonstrated superior activity compared to trastuzumab and capecitabine alone in patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with and without brain metastases,” said Roger Dansey, M.D., chief medical officer at Seattle Genetics.
“The decision by the FDA to grant Breakthrough Therapy designation to tucatinib recognizes the urgent need for new medicines that can impact the lives of those with HER2-positive metastatic breast cancer. We intend to submit a New Drug Application to the FDA and an MAA to the EMA by the first quarter 2020, with the goal of making tucatinib available to patients in this setting as soon as possible.”