FDA Grants Accelerated Approval to Therapy for Previously Treated Metastatic TNBC

Officials with the FDA have approved sacituzumab govitecan-hziy (Trodelvy, Immunomedics Inc) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease.

Sacituzumab govitecan-hziy is the first antibody-drug conjugates approved by the FDA specifically for relapsed or refractory metastatic TNBC and is the first FDA approved anti-Trop-2 ADC, according to Immunomedics.

Sacituzumab govitecan-hziy’s approval comes from the observed objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter phase 2 study. Continued approval may depend on verification of clinical benefit in the confirmatory phase 3 ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee for compelling evidence of efficacy across multiple endpoints.

Sacituzumab govitecan-hziy demonstrated an ORR of 33.3% and a median DoR of 7.7 months in 108 adult TNBC patients who had previously received a median of 3 prior systemic therapies in the metastatic setting.

The most common adverse effects occurring in 25% or more of patients included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain. There were no deaths related to the treatment, and no severe causes of neuropathy or interstitial lung disease.

REFERENCE

FDA grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer [news release]. Morris Plains, NJ; Immunomedics: April 22, 2020. https://www.globenewswire.com/news-release/2020/04/22/2020193/0/en/FDA-Grants-Accelerated-Approval-for-Immunomedics-Trodelvy-in-Previously-Treated-Metastatic-Triple-Negative-Breast-Cancer.html. Accessed April 22, 2020.