Trodelvy Granted Full Approval for Triple Negative Breast Cancer

April 7, 2021 – The U.S. FDA has granted full approval for Trodelvy® (sacituzumab govitecan-hziy), manufactured by Gilead, to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults who have received two or more prior systemic therapies, at least one of which was for metastatic disease. Trodelvy received accelerated approval in 2020, with full approval contingent on verification of clinical benefit in a confirmatory clinical study.

The full approval for Trodelvy expands the indication granted upon its 2020 accelerated approval, which was for the treatment of metastatic TNBC in adults who had received at least two prior therapies for metastatic disease.

Accounting for approximately 15% of all breast cancers, TNBC is an aggressive disease that tests negative for estrogen or progesterone receptors and for overproduction of the HER2 protein. This can limit treatment options, as targeted therapies for breast cancer usually rely on at least one of these three identifiers to recognize and attack cancerous cells. Compared to other forms of breast cancer, TNBC tends to spread more quickly and have a worse prognosis. The five -year survival rate once the cancer has metastasized can be as low as 12%.

In a confirmatory study, Trodelvy delivered a 57% reduction in the risk of disease worsening or death and extended the median length of progression-free survival to 4.8 months compared to 1.7 months with chemotherapy. It also demonstrated improvements in median overall survival – 11.8 months with Trodelvy versus. 6.9 months with chemotherapy, translating to a 49% reduction in the risk of death.

Recommended dosing is 10mg/kg of the patient’s body weight administered via intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles until disease progression or unacceptable toxicity occur. While the first infusion should take place over the course of three hours, subsequent infusions can be done in 1-2 hours, depending on tolerability. Patients should be observed for signs of infusion reactions for at least 30 minutes after every infusion.

A black box warning cautions that Trodelvy can cause severe or life -threatening neutropenia, which is an abnormally low level of neutrophils, a type of white blood cell, that can increase the risk of infection. There is also a black box warning for severe diarrhea.