The FDA approves sacituzumab govitecan (TRODELVY) for the patients with metastatic triple-negative breast cancer and metastatic urothelial carcinoma
April 13, 2021
In April 2020, sacituzumab govitecan (TRODELVY) was granted an accelerated approval from the FDA for the patients with nonresectable locally advanced breast cancer and metastatic triple negative breast cancer whose diseases was progressed even after two or more treatments.
On April 7, 2021, the FDA granted the regular approval to sacituzumab govitecan based on the results of the confirmatory clinical trial, ASCENT (NCT02574455).
Sacituzumab govitecan is an antibody-drug conjugate (ADC), meaning that a chemotherapy drug, govitecan is attached to a monoclonal antibody drug targeting the protein called Trop-2. Because many cancer cells have high numbers of Trop-2 on their surface, the drugs will more readily bind to cancer cells than to healthy cells and release the chemotherapy drug into cancer cells. Thus, it is less toxic than systemic use of chemotherapy drugs alone.
In the ASCENT trial, the patients treated with sacituzumab govitecan did not show cancer progression for median 4.8 months, whereas cancer of those with chemotherapy drug progressed just after median 1.7 months. Moreover, the patients treated with the drug survived for median 11.8 months compared to those with chemotherapy alone for median 6.9 months.
On April 13, 2021, the FDA also granted an accelerated approval to sacituzumab govitecan for the patients with metastatic urothelial carcinoma whose cancer progressed after the treatment of immune checkpoint inhibitors or platinum-based chemotherapy. Only 5-10% of the patients with metastatic urothelial carcinoma patients survive 2 years after the initial diagnosis. Thus, there is an urgent need of more efficacious treatments for these patients.
This conditional approval is based on the phase 2 TROPHY-U-01 trial (NCT03547973), in which 27.7 % of the patients responded to the drug for median 7.2 months. A phase 3 trial confirmatory trial TROPiCs-04 (NCT04527991) is recruiting patients with metastatic or locally advanced unresectable urothelial carcinoma whose cancer has progressed even after the treatments of immune checkpoint inhibitors or platinum-based chemotherapy. To check your eligibility, please discuss with your oncologists or contact us at minji@MJpatietnadvocate.com.