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U.S. FDA Fast Track Designation Granted for Envafolimab in Soft Tissue Sarcoma Subtypes

Release time:2022-09-16

On September 14,Envafolimab, the world's first subcutaneously PD-L1 inhibitor has received Fast Track designation granted by the U.S. FDA to be used in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).


Envafolimab is currently marketed in China under the strategic collaboration of Simcere, 3DMed and Alphamab Oncology. It was approved in China by Chinese NMPA in November 2021 for adult patients with advanced solid tumors who have unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair gene-deficient (dMMR). 

Driven by collaborating parties, Envafolimab has launched clinical trials for multiple tumor in China, the United States and Japan, and has previously been granted orphan drug designation by the FDA for the treatment of soft tissue sarcoma and cholangiocarcinoma. The FDA Fast Track designation increase the chance to accelerate the approval of this novel product in the United States.  


In addition, the clinical study of Envafolimab has made several important progresses in the international and national oncology academic circle:


1. The results of Envafolimab Japanese phase 1 clinical study were published in Investigational New Drugs (IF: 3.651). The results has confirmed its durable anti-tumor activity against advanced solid tumors and that the treatment was well tolerated by the patients.


2. A Phase 2 clinical data of Envafolimab + Lenvatinib combined with TACE in the treatment of liver cancer were presented at the 12th Asia-Pacific Primary Liver Cancer Expert (APPLE) 2022 Annual meeting


3. Four clinical studies on Envafolimab in the treatment of advanced solid tumors were included in the 2022 CSCO Annual Academic Meeting Abstract. Of these, two studies will be presented by oral presentation.


These progresses further confirms that the clinical value of the product has been internationally recognized and that this innovative product is expected to benefit more patients globally.