Recent FDA Approvals for Triple-Negative Breast Cancer
The FDA has approved several treatments for triple-negative breast cancer (TNBC) in recent years, focusing on immunotherapy, antibody-drug conjugates, and PARP inhibitors. Here are three notable ones from 2021 onward.
What is pembrolizumab plus chemotherapy (Keytruda)?
In July 2021, the FDA granted full approval to pembrolizumab (Keytruda) combined with chemotherapy (paclitaxel and carboplatin) for high-risk early-stage TNBC in neoadjuvant and adjuvant settings.[1] This followed the KEYNOTE-522 trial, where it reduced the risk of event-free survival by 37% compared to chemotherapy alone. It's administered every three weeks for up to nine cycles pre-surgery, then 27 weeks post-surgery.
When was sacituzumab govitecan approved (Trodelvy)?
The FDA expanded approval for sacituzumab govitecan (Trodelvy) in April 2023 for unresectable locally advanced or metastatic TNBC after two prior systemic therapies.[2] Originally accelerated in 2020 and converted to full approval in 2021, this antibody-drug conjugate targets TROP-2. The ASCENT trial showed a median overall survival of 12.1 months versus 6.7 months with standard chemotherapy.
How does talazoparib with enzalutamide work?
In August 2024, the FDA approved talazoparib (Talzenna) combined with enzalutamide (Xtandi) for unresectable or metastatic TNBC with BRCA1/2 mutations after prior chemotherapy.[3] This PARP inhibitor and androgen receptor blocker combo improved progression-free survival to 8.5 months from 5.6 months in the TALENT trial. It's for patients with specific germline or somatic mutations.
What about upcoming or related approvals?
Datopotamab deruxtecan (Dato-DXd) received priority review in 2024 for pretreated metastatic TNBC, with a decision expected in 2025 based on TROPION-PanTumor01 data showing 4.4-month median progression-free survival.[4] These approvals reflect a shift toward targeted therapies, improving outcomes in this aggressive subtype lacking ER, PR, and HER2 expression.
[1]: FDA.gov - Keytruda Approval
[2]: FDA.gov - Trodelvy Approval
[3]: FDA.gov - Talzenna + Xtandi Approval
[4]: FDA.gov - Priority Review