Merck's Keytruda Nears Eighth Indication Approval in China

Reprinted from | Medical Insights

Public disclosures from China's National Medical Products Administration (NMPA) indicate that the review status of the marketing application for a new indication of MSD's PD-1 inhibitor pembrolizumab injection (Keytruda, pembrolizumab) has been updated to: Under Review. This means that pembrolizumab is expected to receive approval in China for its eighth indication in the near future.

Source: NMPA Official Website

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 the body's immune cells. Since the introduction of this novel immuno-oncology drug, it has been approved globally for the treatment of multiple cancer types.

In China, pembrolizumab injection has already been approved for seven indications, which are:

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

Indicated for first-line monotherapy in patients with 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 a PD-L1 tumor proportion score (TPS) ≥1% as determined 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 determined by a validated assay, following failure of prior first-line systemic therapy;

As a single agent for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with tumors expressing PD-L1 (CPS ≥ 20) as determined by a validated test;

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

On November 23, 2020, a marketing application for a new indication of pembrolizumab was submitted in China and accepted. With the application now under regulatory review, this indicates that the drug is expected to gain approval for an additional indication in China in the near future.

According to the China Drug Clinical Trial Registration and Information Disclosure Platform, pembrolizumab has been registered for dozens of clinical trials in China, most of which are international multi-center Phase III studies. In addition to already approved indications, clinical trials that have advanced to Phase III are also investigating indications such as hepatocellular carcinoma (HCC), gastric cancer, breast cancer, gastroesophageal junction adenocarcinoma, cervical cancer, prostate cancer, urothelial carcinoma, biliary tract cancer, and endometrial cancer, among others.

References:

[1] Drug Registration Progress Query. Retrieved Aug 16, 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] FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer. Retrieved June 29, 2020, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-line-immunotherapy-patients-msi-hdmmr-metastatic-colorectal-cancer

[3] Chinese Clinical Trials Registration and Information Disclosure Platform. Retrieved August 20, 2021, from http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml

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