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FDA Grants Antibody-Drug Conjugate Breakthrough Designation in TNBC

Jason M. Broderick @jasoncology
Published: Friday, Feb 05, 2016

Sacituzumab govitecan (IMMU-132) has received an FDA breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate. 

The planned phase III trial of sacituzumab govitecan, on which Immunomedics is working with the FDA, is a multicenter, international, randomized, open-label study that aims to accrue 328 patients with relapsed/refractory metastatic TNBC following ≥2 prior chemotherapies, including a taxane. The primary outcome measure will be PFS, with secondary endpoints including OS, ORR, duration of response, and time to onset of response.  

Bardia A, Diamond R, Mayer A, et al. Safety and efficacy of anti-Trop-2 antibody drug conjugate, sacituzumab govitecan (IMMU-132), in heavily pretreated patients with TNBC. Presented at: the 2015 San Antonio Breast Cancer Symposium; San Antonio, TX; December 8-12, 2015. PD3-06.

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