Sacituzumab Govitecan Approval for Advanced or Metastatic Urothelial Cancer

WATERTOWN, Mass. - April 27, 2021 - PRLog -- The FDA has granted accelerated approval to Sacituzumab Govitecan on April 13, 2021 for use in adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

The drug was created by site-specifically conjugating a TROP-2-targeting antibody with a drug to antibody ratio of 7.6 (which is about twice that of other antibody-drug conjugates) of the moderately toxic drug, SN-38, the active metabolite of irinotecan, using a pH-sensitive linker.

Bladder cancer
Urothelial cancer is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably.

According to the American Cancer Society, an estimated 83,720 people in the United States will be diagnosed with bladder cancer in 2021, and almost 90% of those diagnoses will be Urothelial cancer. The data shows an increase of approximately 3% compared to the prior year. That means that on average, 228 people will suffer bladder cancer each day this year.  Furthermore, an estimated 17,000 patients will not survive the disease and there are thought to be more than 600,000 people living with bladder cancer in the United States, more than the population of the state of Wyoming.

"Bladder cancer patients need as many treatment options as possible, and we are pleased that Sacituzumab Govitecan can be a potentially viable treatment for them," she concluded.

Treatment options
"Only a fraction of patients derive long-term benefit from previously approved cytotoxic therapy or immunotherapy, leaving a great unmet need for treatment options for patients with advanced urothelial cancer who have progressed on first- and second-line therapies," said Scott T. Tagawa, MD, MS, FACP, Professor of Medicine and Urology at Weill Cornell Medicine, an oncologist at New York-Presbyterian/Weill Cornell Medical Center and principal investigator of the TROPHY study and a paid consultant for Gilead Sciences.
"The response rate and tolerability seen with Sacituzumab Govitecan may provide physicians an effective new treatment option for patients whose cancer continues to progress even after multiple therapies," Tagawa added.

Biochempeg is a leading worldwide PEG & ADC linkers supplier that dedicated to manufacturing and supplying a variety of high purity PEG linkers and ADC linkers to empower ADC drug research & development. Product 2-((Azido-PEG8-carbamoyl)methoxy)acetic acid is a fragment of Sacituzumab govitecan(IMMU-132), we have this product in stock, we can also support custom synthesis with different quantities based on customers' requirment.

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