The FDA has accepted a biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease, according to a statement from the company developing the antibody-drug conjugate (ADC), Immunomedics.1
The phase III ASCENT trial is currently exploring sacituzumab govitecan in comparison with treatment of physician choice for patients with metastatic TNBC. The trial, which has fully accrued 529 patients, is expected to report results in 2020 (NCT02574455). The current BLA for sacituzumab govitecan, if approved, will provide an accelerated approval for the medication. Finding from the ASCENT trial will act as confirmation.
- Immunomedics Announces FDA Acceptance for Filing of Biologics License Application Resubmission for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer. Immunomedics, Inc. Published December 26, 2019. https://bit.ly/37iQ4ZD. Accessed December 27, 2019.
- Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application. Immunomedics. Published January 17, 2019. https://bit.ly/2sBcDGG?rel=0" . Accessed January 17, 2019.
- Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Eng J Med. 2019;380:741-751. doi: 10.1056/NEJMoa1814213.
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