Merck's Keytruda Receives Eighth Indication Approval in China for First-Line Treatment of Advanced Esophageal Cancer

On September 3, the National Medical Products Administration (NMPA) announced that the eighth indication for MSD's PD-1 inhibitor pembrolizumab injection (Keytruda, pembrolizumab, abbreviated as the "K drug") has been approved in China. The Keytruda-plus-chemotherapy regimen will soon be applied to the first-line treatment of advanced esophageal cancer.

Pembrolizumab is a blockbuster PD-1 inhibitor developed by MSD. By blocking the PD-1/PD-L1 signaling pathway, it enhances the anti-cancer response of human immune cells. Since its introduction as a novel immune-oncology drug, it has been approved globally for the treatment of multiple cancer types.

In China, pembrolizumab injection has been approved for 7 indications, which are as follows:

Indicated for the treatment of unresectable or metastatic melanoma following failure of first-line therapy;

Indicated for the first-line monotherapy of locally advanced or metastatic non-small cell lung cancer (NSCLC) that is epidermal growth factor receptor (EGFR) mutation-negative and anaplastic lymphoma kinase (ALK)-negative, with PD-L1 tumor proportion score (TPS) ≥ 1% as assessed by a test approved by the National Medical Products Administration (NMPA);

Pemetrexed in combination with platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-squamous non-small cell lung cancer that is EGFR mutation-negative and ALK-negative;

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

As monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as assessed by a validated test, and who have failed prior first-line systemic therapy;

As monotherapy for 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) as determined by a validated test;

and as monotherapy for the first-line treatment of patients with unresectable or metastatic colorectal cancer (CRC) with KRAS, NRAS, and BRAF wild-type tumors, and high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

Reference: National Medical Products Administration, Yiyao Guanlan