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In a Phase IIb trial in 80 subjects, Trodelvy offered an overall response rate of 38.8%.
June 10, 2022
Everest Medicines has received approval from China’s National Medical Products Administration (NMPA) for Trodelvy (sacituzumab govitecan or SG) to treat unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in adults.
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The treatment is intended for TNBC patients who have priorly received two or more systemic therapies, with a minimum of one for metastatic disease.
Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate.
It is said to be the first drug of Everest to receive approval for a New Drug Application (NDA) to launch in China.
The NMPA accepted the company’s NDA for Trodelvy with Priority Review designation in May last year.
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In November last year, Everest reported topline data from the Phase IIb EVER-132-001 clinical trial of Trodelvy in 80 subjects.
According to the findings, the trial met the primary endpoint with an overall response rate (ORR) of 38.8%.
Furthermore, the data was in line with findings from the international Phase III ASCENT trial.
The company anticipates launching the commercial sales of Trodelvy in China in the fourth quarter of this year.
Apart from mainland China, Trodelvy is approved in Singapore while the company is working with regulatory authorities in Taiwan, South Korea and Hong Kong to review its applications for the indication for use in adults.
Everest Medicines Oncology/Immunology chief medical officer Yang Shi said: “The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease.
“We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumour types as well as earlier lines of therapy.”
In April this year, Everest and China Resources Pharmaceutical Group (CR Pharma) entered a memorandum of understanding for a partnership to set up a company focused on messenger ribonucleic acid (mRNA) vaccine development.
Free Whitepaper
Cell and Gene Therapy: Oncology Clinical Trial Trends in the United States
Cell and gene therapies (CGT) have seen expansive clinical development and revenue growth over the past 5 years across various therapeutic areas.With the approval of 12 new therapies and the initiation of over 2,900 clinical trials between the analysis period of 2016 -2021, it is evident there is extensive investment in the innovation of CGT. Notably, oncology is the leading therapeutic area, with the highest percentage of new clinical development year-on year compared to other CGT therapy areas, indicating a high level of unmet needs and increased industry investment in the space.Access GlobalData’s new whitepaper, Cell and Gene Therapy: Oncology Clinical Trial Trends in the United States to gain a better understanding of the developments, challenges and opportunities in CGT including exclusive insights on promising future oncology CGT assets in development.The white paper covers:
- The key takeaways of cell and gene therapy
- Extensive background on the uptake of cell and gene therapy
- Insights and outlook of cell and gene therapy trials in the US
- An analysis of the top oncology cell and gene therapy assets and developers
Enter your details here to receive the free whitepaper.
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This content was updated on 25 January 2024
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