The breast cancer expert discussed the implications of this approval, as well as the data that led to the approval of sacituzumab govitecan-hziy.
In an interview with CancerNetwork®, Hope Rugo, MD, breast oncologist at the UCSF Carol Franc Buck Breast Care Center, spoke about the accelerated approval of sacituzumab govitecan-hziy (Trodelvy) by the FDA in patients with metastatic triple-negative breast cancer (TNBC) who received 2 prior therapies for metastatic disease.
“This is such an important time to have a new drug approved that has significant efficacy for the treatment of the cancer that has the shortest median survival after diagnosis of metastatic disease,” said Rugo. “This also is a really critical point when thinking about having another treatment option for patients in this very difficult situation with essentially no good options for treatment”
This is the first approval by the FDA for the specific treatment of relapsed or refractory TNBC. The approval was based on positive results from a single-arm, multicenter phase II study which was designed to evaluate objective response rate (ORR) and duration of response (DOR) of the agent in patients with metastatic TNBC.
“This really could be a life-line for some patients and allow them another treatment with a novel agent, a novel chemotherapy approach, that results in better disease control, better options for disease control, with a reasonably tolerable agent,” Rugo explained.
The verification of clinical data in the phase III ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee (DSMC) for “compelling evidence of efficacy across multiple endpoints,” will be essential for the continued approval of sacituzumab govitecan.
This segment comes from the CancerNetwork® portion of the MJH Life Sciences National Broadcast, airing daily on all MJH Life Sciences channels.
FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer [news release]. Morris Plains, New Jersey. Published April 22, 2020. 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 27, 2020.