FDA Approves Sacituzumab Govitecan for Pretreated, Metastatic TNBC

The FDA granted a regular approval to sacituzumab govitecan (Trodelvy) for previously treated patients with unresectable locally advanced or metastatic triple-negative breast cancer.

The FDA granted a regular approval to sacituzumab govitecan (Trodelvy) for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who had 2 or more previous systemic therapies, with at least 1 being for metastatic disease.

Recommended dosing for the drug is 10 mg/kg once a week on days 1 and 8 of 28-day treatment cycles or until progression or unacceptable toxicity.

The approval was based on findings from the multicenter, open-label, randomized ASCENT trial (NCT02574455), which included 529 patients with unresectable or locally advanced metastatic TNBC who experienced progression on 2 or more chemotherapies, one of which could have been in the neoadjuvant setting if progression occurred within 12 months.

Participants in ASCENT were randomized 1:1 to receive either intravenous sacituzumab govitecan or physician’s choice of single-agent chemotherapy.

The primary endpoint of the study was progression-free survival (PFS) in patients without brain metastases, per RECIST 1.1 criteria. Average PFS was 4.8 months in the sacituzumab govitecan arm, compared with 1.7 months in the chemotherapy arm.

Sacituzumab govitecan also bested chemotherapy when it came overall survival (OS), with median OS being 11.8 months in the treatment arm compared to 6.9 months in the control arm.

Common adverse events from sacituzumab govitecan, which occurred in more than 25% of patients, were nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.