Bristol-Myers Squibb’s PD-1 Inhibitor’s New Indication Application for Listing Enters "Under Approval"

According to the announcement of the National Food and Drug Administration (NMPA) of China, Bristol-Myers Squibb Company (BMS) Nivolumab Injection (Odivo)’s new indication listing application status has been updated to “under review”, which means The drug is expected to usher in new indications in China in the near future
.

Screenshot source: NMPA official website

Nivolumab is a PD-1 immune checkpoint inhibitor developed by BMS.
Its mechanism of action is to use the body's own immune system to help the body recover its anti-tumor immune response.
This feature has made it a variety of tumors.
Important treatment options
.

Since its approval in July 2014, Navulimab has been approved in more than 60 countries and regions to treat more than ten cancer types, covering lung cancer, head and neck cancer, stomach cancer, esophageal cancer, liver cancer, kidney cancer, colorectal cancer urothelial carcinoma, melanoma, Hodgkin's lymphoma, pleural tumors
.

In China, nivolumab was first approved for marketing in 2018
.

For the treatment of epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative, disease progression or intolerable locally advanced or metastatic non-small cell lung cancer after previous platinum-containing chemotherapy ( NSCLC) adult patients;

It is used for patients with recurrent or metastatic head and neck squamous cell carcinoma who have disease progression during or after treatment with platinum-containing regimens and positive tumor PD-L1 expression (PD-L1 expression tumor cells ≥ 1%);

For the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who have received two or more systemic treatments in the past;

Combined with ipilimumab injection for unresectable, newly treated adult patients with non-epithelioid malignant pleural mesothelioma
.

In December 2020, the marketing application for two new indications of nivolumab injection was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration
.

Screenshot source: CDE official website

According to the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, a number of clinical studies are currently being carried out in China for nivolumab injection.
The indications involved include mid-stage liver cancer, estrogen receptor positive (ER+)/human epidermal growth factor Body 2 negative (HER2-) primary breast cancer, resectable stage II-IIIB non-small cell lung cancer, male metastatic castration-resistant prostate cancer, advanced hepatocellular carcinoma, recurrent or metastatic colorectal cancer, etc.

.

Reference

[1] Inquiry on the progress of drug registration in the State Drug Administration of China.

[2] The world's first dual immunotherapy was approved in China! "Immune Gemini" for the first-line treatment of malignant pleural mesothelioma.