On 7th April 2021, sacituzumab govitecan received US-FDA approval to treat individuals having unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
The ASCENT study was carried out to examine the efficacy and safety of sacituzumab govitecan in 529 subjects having unresectable locally advanced or mTNBC who had relapsed after at least two prior systemic chemotherapies, one of which could be in the adjuvant or neoadjuvant setting, if the disease advancement occurred within twelve months.
In April 2020, this agent was given accelerated approval for individuals suffering from mTNBC who were administered at least two previous therapies for metastatic cancer. This randomized, multicenter, open-label study was the confirmatory study for the accelerated approval.
The recruited individuals were randomly assigned to (i) Group 1 (n=267): Received an intravenous infusion of sacituzumab govitecan (10 mg/kg) on days one and eight of a 21-day cycle (ii) Group 1 (n=262): Received physician’s choice of single-agent chemotherapy.
The major outcome was
- progression-free survival in individuals without brain metastases at baseline.
Other outcomes were
- progression-free survival for the full population (with and without brain metastases)
- overall survival
Among all randomized participants (with and without brain metastases), the median progression-free survival and median overall survival for individuals receiving sacituzumab govitecan and individuals receiving chemotherapy are depicted in the below table:
|Patients receiving sacituzumab govitecan||Patients receiving chemotherapy|
|Median progression-free survival||4.8 months||1.7 months|
|Median overall survival||11.8 months||6.9 months|
Vomiting, abdominal pain, alopecia, nausea, constipation, neutropenia, decreased appetite, diarrhea, rash, fatigue, and anemia were the most commonly noted adverse reactions (incidence >25%) in subjects treated with sacituzumab govitecan. The suggested dosage of sacituzumab govitecan is 10 mg/kg once weekly on days one and eight of 21-day treatment cycles until unacceptable toxicity or disease advancement.
|Original title of the article||FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer|