Trodelvy added as preferred regimen within first-line metastatic triple-negative breast cancer in NCCN (Clinical Practice) Guidelines in Oncology – Gilead Sciences

Gilead Sciences Inc. announced Trodelvy (sacituzumab govitecan-hziy) has now been added to the NCCN Guidelines as a category 1 preferred first-line treatment option for people with metastatic triple-negative breast cancer (TNBC) whose disease is PD-L1 negative (CPS <10) and no germline BRCA1/2 PV. Category 1 is the highest-level recommendation by the National Comprehensive Cancer Network (NCCN). The NCCN Guidelines now also include the combination of Trodelvy with the PD-1 inhibitor Keytruda (pembrolizumab) as a category 2A preferred option for people with first-line metastatic TNBC whose tumors test positive for PD-L1 (CPS ≥10).

“For the last 20 years, there has been limited meaningful progress to treat people with first-line metastatic triple-negative breast cancer,” said Dr. Mika Kakefuda Derynck, Senior Vice President, Oncology Therapeutic Area Head at Gilead Sciences. “These updated guidelines validate the potential for Trodelvy to become a backbone treatment option for first-line metastatic TNBC patients.”

The NCCN update is based on positive results from two Phase III studies—ASCENT-03 and ASCENT-04. Gilead has submitted supplemental applications to both the FDA and the EMA for approval of Trodelvy in these indications based on these studies.