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New breakthrough therapy designation for cervical cancer

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Innovent Biologics, Inc. announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI310 in combination with sintilimab for the treatment of patients with recurrent or metastatic cervical cancer.

The NMPA BTD for IBI310 was based on results from First part of a Phase 2 trial (CDE Registration No. CTR20202017). This study enrolled 205 patients in patients with advanced cervical cancer. The safety profile in this study was consistent with that observed in previously reported studies, and no additional safety signals were identified for the combination of IBI310 and sintilimab. Relevant study results will be published at an upcoming medical conference in 2022.

“We are glad to see the NMPA grant Breakthrough Therapy Designation based on the results of First part of Phase 2 data of IBI310,” said Dr. Hui Zhou, Senior Vice President of Innovent. “Patients with advanced cervical cancer currently have limited treatment options. Patients treated with chemotherapy show limited clinical benefit and the overall survival is limited to a few months. The results of First part of the Phase 2 study of IBI310 in combination with sintilimab show potential for this combination as a new treatment option for patients in need.  We look forward to obtaining more data from the ongoing pivotal Phase 2 trial which may support a future regulatory application in China for IBI310 in combination with sintilimab in recurrent or metastatic cervical cancer.”

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE, but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.

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