Today, Gilead Sciences announced that the U.
FDA has accelerated the approval of its Trop-2 antibody conjugate drug Trodelvy (sacituzumab govitecan-hziy) to expand its scope of use for the treatment of locally advanced or metastatic urothelium Cancer patients.
They have been treated with platinum-containing chemotherapy and PD-1 or PD-L1 inhibitors.
This is Trodelvy’s second FDA approval this year.
Last week it received full FDA approval for the treatment of triple-negative breast cancer.
In 2020, approximately 580,000 people worldwide will be diagnosed with bladder cancer.
Urothelial cancer accounts for 90% of all bladder cancers and can also occur in the renal pelvis, ureter, and urethra.
After the failure of initial platinum-containing therapy, 80% of advanced patients will not respond to PD-1 or PD-L1 inhibitor therapy.
Trop-2 is highly expressed in various human epithelial cancers, including breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer and ovarian cancer.
Trop-2 overexpression plays a key role in tumor growth.
In addition, in several cancers such as breast cancer, the high expression of Trop-2 has also been found to be associated with more aggressive diseases and poor prognosis.
Trodelvy is an antibody-conjugated drug composed of an antibody targeting Trop-2 and the active metabolite SN-38 of the chemotherapeutic drug irinotecan.
It can deliver SN-38 into cancer cells by binding to Trop-2 protein.
It is worth mentioning that Everest has the development rights of this innovative antibody conjugate drug in Greater China.
It has been approved for Phase 3 clinical trials in China to treat metastatic triple-negative breast cancer and advanced urothelial cancer that have received at least 2 lines of previous treatment.
This accelerated approval is based on the results of a single-arm phase 2 clinical trial.
Among 112 patients who can be evaluated for efficacy, 27.
7% of patients achieved remission, of which the complete remission rate was 5.
The median duration of response was 7.
2 months (95% CI: 4.
Note: The original text has been deleted
 US FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer.
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