December 4, 2023, according to the official website of National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE), the subcutaneous PD-L1 antibody injection Envafolimab (Enweida®) has been officially included in the "List of Breakthrough Therapies ". It is indicated to be used in combination with lenvatinib for the treatment of non-MSI-H/non-dMMR advanced endometrial cancer patients who have failed or cannot tolerate at least one prior platinum-based chemotherapy.
According to the Working Procedures for the Review of Breakthrough Therapy Drugs (Interim) issued by NMPA, in order to encourage the research and development of drugs with obvious clinical advantages, the products entering the breakthrough therapy procedures may enjoy prioritized resource allocation by CDE in terms of safety-related and technology-related communications, meetings and consultation during clinical development. They may also be qualified to apply for conditional approval and priority review at drug registration stage, may significantly shorten procedure timeframe and accelerate the process of drug commercialization.
Endometrial cancer is the second most frequent gynecological malignancy in China. Some of the patients are diagnosed at advanced stage and tend to experience recurrence and metastasis after treatment. Currently there is no standard posterior line treatment for advanced and recurrent endometrial cancer. There is a clear and urgent clinical demand for new and more effective treatment in this area. Data from the Ib/II trial of Envafolimab combined with lenvatinib in advanced solid tumors were presented as poster at the annual meeting of the European Congress of Medical Oncology (ESMO) in 2023, bringing preliminary validation of the anti-tumor efficacy and safety for this regimen.
Envafolimab is the world's first subcutaneously administered Immuno-Oncology PD-L1 antibody drug developed through a strategic cooperation of Simcere，3DMed, and Alphamab. It is currently commercialized in mainland China by Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Co., Ltd. On 24 Nov 2021, Envafolimab was approved by NMPA for the treatment of adult patients with unresectable or metastatic MSI-H/dMMR solid tumors.
Up until November 2023, Envafolimab was recommended by 12 clinical guidelines in China and the US including 3 Chinese versions of the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of multiple malignancies such as tumors of the GI tract, gynecological tumors, and immune checkpoint inhibitors.