Gilead's Trodelvy Wins FDA Regular Approval For Triple-Negative Breast Cancer

The FDA has granted regular approval to Gilead Sciences Inc's GILD Trodelvy (sacituzumab govitecan) for an aggressive and tough-to-treat type of breast cancer.
The indication covers people with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Initially, Trodelvy was granted accelerated approval by the FDA in April 2020 and, therefore, needed efficacy to be confirmed in further trials for full approval.
The FDA based its full approval on results from the ASCENT trial.
Trodelvy showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death.
Among all patients, median progression-free survival for patients who received Trodelvy was 4.8 months compared to 1.7 months in those who received chemotherapy.
Moreover, treatment with Trodelvy was associated with a median overall survival of 11.8 months compared to 6.9 months for those who received chemotherapy.
Side effects in more than 25% of patients who received Trodelvy included, but were not limited to, nausea, fatigue, anemia, constipation, rash, and decreased appetite.
In March, the European Medicines Agency (EMA) validated the marketing application for sacituzumab govitecan-hziy for triple-negative breast cancer. The application is now under accelerated review by the EMA.
Trodelvy, which Gilead had acquired as part of its $21 billion Immunomedics buyout, is an antibody-drug conjugate targeting Trop-2, a protein frequently expressed in multiple types of epithelial tumors.
Price Action: GILD shares are up 0.79% at $66.12 in the premarket trading session on the last check Thursday.