The China National Medical Products Administration (NMPA) has recently granted breakthrough therapy (BTD) designation to Innovent Biologics’ (Innovent) IBI310 in combination with sintilimab to treat patients with recurrent or metastatic cervical cancer. The move will further improve access to targeted treatment options in the current treatment paradigm of cervical cancer, says GlobalData, a leading data and analytics company.

Anupama Mishra, Pharma Analyst at GlobalData, comments: “The current treatment paradigm of cervical cancer centers largely on surgery, chemotherapy, and radiotherapy. Radiotherapy is the mainstay treatment for all advanced cervical cancer patients who cannot undergo surgery. Furthermore, chemotherapeutics such as carboplatin and cisplatin are in active usage. However, bevacizumab and its biosimilar are the only immunotherapy approved for cervical cancer.”

According to GlobalData’s Pharma Intelligence Center, there are two drugs in the pre-registration phase and 16 drugs in Phase III to treat cervical cancer in China. The two drugs in the pre-registration phase are Sorrentio Therapeutics and Lee Pharmaceutical’s socazolimab and Akeso’s cadonilimab.

In September 2021, Akeso submitted new drug application (NDA) to NMPA for cadonilimab as monotherapy treatment for second/third line recurrent and metastatic cervical cancer and is currently in the final stage of review. In addition, in November 2021, NMPA accepted the NDA application for socazolimab to treat recurrent or metastatic cervical cancer.

Drug accessibility is a significant barrier for cervical cancer treatment in China. Several effective drugs such as Abraxane are still used off-label in China as they are neither approved by NMPA nor are listed on the National Reimbursement Drug List (NRDL). Hence, drug access and regulatory approval are key factors for commercial success in China.

According to GlobalData’s Pharma Intelligence Center, there will be 61,305 diagnosed incident cases of cervical cancer in urban China in 2022, of which roughly 48% will be recurrent or metastatic cervical cancer.

Mishra concludes: “The BI310 and sintilimab combination will create an effective immunotherapy treatment option for recurrent or metastatic cervical cancer in China. As sintilimab has already been approved and included in the NRDL in China for other approved indications, this will help patients get rapid access to this candidate in China. Additionally, the BTD designation will help in obtaining rapid review status by the Center for Drug Evaluation (CDE).”