FDA Grants Regular Approval to Sacituzumab Govitecan for TNBC

In Clinical Studies News by Barbara Jacoby

From: onclive.com

The FDA has 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 have previously received 2 or more systemic therapies, at least 1 of them for metastatic disease.

The Trop2-directed antibody and topoisomerase inhibitor drug conjugate was previously granted an accelerated approval in April 2020 for use in patients with metastatic TNBC who had received at least 2 prior therapies for metastatic disease.

Data from the confirmatory phase 3 ASCENT trial (NCT02574455) supported the decision for the full approval.

The trial enrolled a total of 529 patients with unresectable locally advanced or metastatic TNBC who had relapsed following at least 2 previous chemotherapies, 1 of which could have been received in either the neoadjuvant or adjuvant setting, if progression occurred within 12 months.

Study participants were randomized 1:1 to receive either sacituzumab govitecan at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle (n = 267) or physician’s choice of single-agent chemotherapy (n = 262).

The primary end point of the trial was progression-free survival (PFS) in patients who did not have brain metastases at baseline per blinded independent centralized review and RECIST v1.1 criteria. Additional efficacy end points comprised PFS for the full population, as well as overall survival (OS).

Among all randomized patients, the median PFS with sacituzumab govitecan was 4.8 months (95% CI, 4.1-5.8) vs 1.7 months (95% CI, 1.5-2.5) with chemotherapy (HR 0.43; 95% CI, 0.35-0.54; P <.0001). Moreover, the median OS was 11.8 months (95% CI, 10.5-13.8) and 6.9 months (95% CI, 5.9-7.6) in the investigative and control arms, respectively (HR 0.51; 95% CI, 0.41-0.62; P <.0001).

The most frequently experienced toxicities in the sacituzumab govitecan arm included nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite, and abdominal pain.


FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer. News release. FDA. April 7, 2021. Accessed April 7, 2021. https://bit.ly/3fOWhUD