The 8th Merck Keytruda new indication is expected to be approved in China in the near future

Transfer from | Pharmaceutical Mission Hills

According to the announcement of the China National Medical Products Administration (NMPA), the listing application for new indications of Merck’s (MSD) PD-1 inhibitor pembrolizumab injection (Keytruda, pembrolizumab) has been updated to: Under review
.

Screenshot source: NMPA official website

Pembrolizumab is a blockbuster PD-1 inhibitor developed by Merck, which blocks the PD-1/PD-L1 signaling pathway and improves the anti-cancer response of human immune cells
.

In China, Pembrolizumab injection has been approved for 7 indications in China, namely:

It is suitable for the treatment of unresectable or metastatic melanoma that has failed first-line treatment;

Applicable to the locally advanced stage of epidermal growth factor receptor (EGFR) gene mutation negative and anaplastic lymphoma kinase (ALK) negative for PD-L1 tumor proportion score (TPS) ≥ 1% approved by the National Medical Products Administration Or first-line monotherapy for metastatic non-small cell lung cancer (NSCLC);

Combination of pemetrexed and platinum-based chemotherapy is suitable for the first-line treatment of metastatic non-squamous non-small cell lung cancer with negative EGFR gene mutation and ALK negative;

Combining carboplatin and paclitaxel is suitable for the first-line treatment of patients with metastatic squamous non-small cell lung cancer;

A single agent is used to evaluate the treatment of patients with PD-L1 expression (comprehensive positive score (CPS) ≥ 10), previously failed first-line systemic therapy, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) through a fully validated test ；

A single agent is used to evaluate the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS≥20) through fully validated tests;

And single agent for KRAS, NRAS and BRAF genes are wild-type, unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair gene defect (dMMR) colorectal cancer (CRC) patients First-line treatment
.

On November 23, 2020, Pembrolizumab submitted a new indication marketing application in China and was accepted
.

According to the Chinese drug clinical trial registration and information disclosure platform, pembrolizumab has registered and carried out dozens of clinical trials in China, most of which are international multi-center phase 3 clinical trials
.

Reference materials:

[1] Drug registration progress query.

[2] FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer.

[3] China Drug Clinical Trial Registration and Information Disclosure Platform.