April 22, 2020
The U.S. FDA has approved Trodelvy™ (sacituzumab govitecan-hziy), manufactured by Immunomedics, to treat adult patients who have metastatic, triple-negative breast cancer (mTNBC) and who have received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate specifically approved for this indication.
Triple-negative breast cancer accounts for approximately one-fifth of all breast cancers. Its name refers to the absence of estrogen and progesterone hormone receptors on the cancer’s cells, as well as a low occurrence of human epidermal growth factor receptor 2 (HER2). Medications designed to target any of these three types of receptors for breast cancer treatment are not typically effective for TNBC patients. Patients who have mTNBC typically have a poor prognosis.
In a clinical study, Trodelvy achieved an overall response rate of 33.3% and a median duration of response of 7.7 months in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting.
Recommended dosing is 10mg/kg of body weight administered via intravenous (IV) infusion once a week on Days 1 and 8 of continuous 21-day treatment cycles. Treatment should continue until disease progression or unacceptable toxicity occur. A black box warning cautions that there is a risk of severe neutropenia (a low count of neutrophils, a type of white blood cell important to immune function) and diarrhea with Trodelvy.
Trodelvy received accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Immunomedics has launched the product at a wholesale acquisition cost (WAC) of $2,012.50 per vial.