FDA approves Trodelvy for first-line metastatic triple-negative breast cancer

The FDA approved Trodelvy as a first-line treatment for metastatic triple-negative breast cancer. It can be used alone for patients who are not candidates for PD-(L)1 inhibitors, or with Keytruda for tumors with PD-L1 CPS of 10 or higher. The approval rests on ASCENT-03 and ASCENT-04, which showed 38% and 35% lower risks of progression or death.

• First-line mTNBC approval as monotherapy for patients not eligible for PD-(L)1 inhibitors
• Combination with Keytruda for PD-L1 CPS of 10 or higher
• ASCENT-03: 38% lower risk of progression or death; ASCENT-04: 35% lower
• Also approved for later-line mTNBC and HR-positive, HER2-negative breast cancer