The Clinical Development of HER2-Targeted Therapies for Breast Cancer

Based on the article linked here: A New Treatment Option for HER2-Positive Breast Cancer | The AACR

The FDA has granted approval for tucatinib (Tukysa), a new HER2-targeted therapeutic, for the treatment of advanced or metastatic HER2-positive breast cancer that has progressed despite treatment with other HER2-targeted therapeutics.

HER2-positive breast cancer accounts for about 15% of new breast cancer cases in the US, and was previously associated with poor patient outcomes. However, the development and FDA approval of HER2-targeted therapeutics, starting with trastuzumab (Herceptin) in 1998, has significantly improved the prognosis for patients with this aggressive form of breast cancer.

Although the current first-line treatment for HER2-positive breast cancer involves a combination of trastuzumab, pertuzumab (Perjeta), and chemotherapy, many patients eventually experience disease progression and require alternative treatments.

The FDA’s approval of tucatinib was based on data from the HER2CLIMB clinical trial, which demonstrated that the addition of tucatinib to trastuzumab and capecitabine significantly improved progression-free survival and overall survival in patients with advanced or metastatic HER2-positive breast cancer, including those with brain metastases.

The study enrolled 410 patients who received the tucatinib combination, and 202 patients who received the placebo combination. Median overall survival was 21.9 months in the tucatinib group and 17.4 months in the placebo group. For patients with brain metastases, 25% of those who received the tucatinib combination had no disease progression after one year, compared to 0% of those who received the placebo combination.

The approval of tucatinib was granted in conjunction with regulatory agencies in Australia, Canada, Singapore, and Switzerland, through the FDA’s Project Orbis initiative. This initiative aims to promote collaboration among regulatory agencies worldwide and accelerate the approval of groundbreaking cancer treatments for patients around the globe.

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