▎The content team editor of WuXi AppTec today, Gilead Sciences announced that the U.
FDA has accelerated its approval of its Trop-2 antibody conjugate drug Trodelvy (sacituzumab govitecan-hziy) to expand the scope of use for local treatment Patients with advanced or metastatic urothelial cancer.
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 evaluate the 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.
“Today’s accelerated approval benefited from the patients and medical workers who participated in the clinical research.
We sincerely thank them for their cooperation,” said Dr.
Merdad Parsey, Gilead’s chief medical officer.
“We will continue to work to quickly bring Trodelvy to those who are difficult to treat.
"Reference:  US FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer.
Retrieved April 13, 2021, from en Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
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