BMS's PD-1 Inhibitor Nivolumab New Indication Application Enters 'Under Review' Status in China

According to public notices from China’s National Medical Products Administration (NMPA), the processing status of the marketing authorization application for a new indication of Bristol-Myers Squibb Company’s (BMS) nivolumab injection (Opdivo) has been updated to "Under Review," indicating that the drug is expected to receive approval for a new indication in China in the near future. Previously, nivolumab has already been approved for four indications in China.

Screenshot source: NMPA official website

Nivolumab is a PD-1 immune checkpoint inhibitor developed by Bristol-Myers Squibb (BMS). Its mechanism of action involves harnessing the body's own immune system to help restore anti-tumor immune responses, a characteristic that has established it as an important treatment option for various cancers.

Since its approval in July 2014, nivolumab has been approved in over 60 countries and regions for the treatment of more than ten cancer types, including lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, renal cancer, colorectal cancer, urothelial carcinoma, melanoma, Hodgkin lymphoma, and pleural tumors. Just yesterday (August 20), BMS announced a new development: the U.S. FDA has approved an additional indication for nivolumab for the adjuvant treatment of urothelial carcinoma.

In China, nivolumab was first granted marketing approval in 2018. To date, the drug has been approved for four indications in China, which are as follows:

Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are epidermal growth factor receptor (EGFR) mutation-negative and anaplastic lymphoma kinase (ALK)-negative, and who have experienced disease progression following prior platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy;

For patients with recurrent or metastatic head and neck squamous cell carcinoma who have experienced disease progression during or after platinum-containing therapy and whose tumors express PD-L1 (PD-L1-positive tumor cells ≥1%);

For the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have previously received two or more systemic therapy regimens;

In combination with ipilimumab injection for the treatment of adult patients with unresectable, previously untreated non-epithelioid malignant pleural mesothelioma.

In December 2020, the marketing authorization applications for two new indications of Nivolumab Injection were accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). The progression of these two applications to the "under approval" status indicates that this innovative therapy, nivolumab, is expected to benefit more patients in China.

Screenshot source: CDE Official Website

According to the Chinese Drug Clinical Trial Registration and Information Public Platform, Nivolumab Injection is currently being evaluated in multiple clinical trials in China, covering indications such as intermediate-stage hepatocellular carcinoma, estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) primary breast cancer, resectable stage II–IIIB non-small cell lung cancer, metastatic castration-resistant prostate cancer in men, advanced hepatocellular carcinoma, and recurrent or metastatic colorectal cancer, among others. Among these, multiple studies of Nivolumab for intermediate-stage hepatocellular carcinoma, ER+/HER2- primary breast cancer, stage II–IIIB non-small cell lung cancer, and advanced hepatocellular carcinoma are all in the Phase III clinical trial stage.

References

[1] National Medical Products Administration. Drug Registration Progress Query. Retrieved Aug 20, 2021, from http://sq.nmpa.gov.cn/datasearch_nmpa/schedule/search.jsp?tableId=43&tableName=TABLE43&columnName=COLUMN464,COLUMN475&title=%D2%A9%C6%B7%D7%A2%B2%E1%BD%F8%B6%C8%B2%E9%D1%AF

[2] World's First Dual Immunotherapy Approved in China! "Immune Duo" for First-Line Treatment of Malignant Pleural Mesothelioma. Retrieved June 11, 2021, from https://mp.weixin.qq.com/s/bdsqkW-DJSiJwl8sp1iMUA

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