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FDA Grants Sacituzumab Govitecan Priority Review for Triple-Negative Breast Cancer

Jason M. Broderick @jasoncology
Published: Wednesday, Jul 18, 2018

Michael Pehl

Michael Pehl

The FDA has granted a priority review designation to a biologics license application (BLA) for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) following at least 2 prior therapies for metastatic disease, according to Immunomedics, the manufacturer of the antibody-drug conjugate.

In February 2016 the FDA granted a breakthrough therapy designation to sacituzumab govitecan as a treatment for TNBC following at least 2 treatments for metastatic disease.
Bardia A, Vahdat LT, Diamond J, et al. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate, as ≥3rd-line therapeutic option for patients with relapsed/refractory metastatic triple-negative breast cancer (mTNBC): efficacy results. Presented at: 2017 San Antonio Breast Cancer Symposium; San Antonio, Texas, December 5-9, 2017. Presentation GS1-07.

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