VIDEO: Practice-changing FDA approvals in metastatic breast cancer

Editor’s note: This is a previously posted video, and the below is an automatically generated transcript to be used for informational purposes. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription.

So if we go back to December 2019, in terms of FDA approvals for breast cancer that have been practice changing for metastatic disease, we see that the FDA provided accelerated approval for HER2 in patients with pretreated HER2-positive metastatic breast cancer, and since then HER2 certainly has entered routine clinical practice, and most recently, at the ESMO meeting in 2021, we saw data from DESTINY-Breast03 that showed really dramatic improvements in PFS compared to TM1 in the second line setting. So, T-DXd or HER2 certainly has moved up in terms of the lines of therapy in HER2-positive disease. Other developments for HER2-positive disease were the approval of tucatinib, full approval in April of 2020, and this was for patients with HER2-positive metastatic disease who've at least received one prior line of anti-HER2 therapy, and importantly, this is the first indication label in breast cancer that has specifically included patients with or without brain metastases. So, that was an important part of the label based on data from the HER2CLIMB trial showing overall survival improvements in patients with brain metastases and in patients without brain metastases. And then if we look in November of 2020, there was accelerated approval of pembrolizumab in combination with chemotherapy, in patients who have metastatic triple-negative breast cancer, whose cancers are PD-L1 positive by the CPS scoring system. And so that has really joined routine clinical practice. And finally, in April of 2021, the regular approval of sacituzumab in patients who have had previous chemotherapy for metastatic triple-negative breast cancer. And the important point there, label indicates to a more prior chemotherapy regimens, but these could be either in the metastatic or adjuvant setting. So somebody could have had an adjuvant regiment relapse, received one line of chemotherapy in the metastatic setting and goes straight to sacituzumab in the second line metastatic setting.