Merck's Keytruda Submits New Indication for Approval in China, with Five Additional Indications Expected to Gain Approval This Year

Sep 04, 2024 14:40 CST Updated 14:40

MSD

Pharmaceutical R&D and Manufacturer

On September 4, the CDE official website showed,Pembrolizumab has a new indication submitted for marketing approval in China,According to the Insight database prediction, this application may be forCombined Chemotherapy for Unresectable, Advanced, or Recurrent Malignant Pleural Mesothelioma。

Image Source:CDE Official Website

Previously, MSD announcedIIIThe results of the KEYNOTE-483 trial, withCompared with single chemotherapy, K Drug Combined with Chemotherapy as First-Line Treatment for Unresectable Advanced Malignant Pleural Mesothelioma Significantly Improves Overall Survival Rate.

In the final analysis of the study, K drug combined with chemotherapy significantly improved OS,Reduced the risk of death by 21%（HR=0.79 [95% CI, 0.64-0.98]），Median OS was 17.3 months（95% CI, 14.4-21.3），Whereas chemotherapy alone was 16.1 months（95% CI, 13.1-18.2）。

Image Source:Insight Database

According to the Insight database "China Market Launch Strategy & Duration Prediction」Function display, currentlyPembrolizumab in China has a total ofSix new indications are under review, with five expected to be approved this year.：

Combined with platinum-based chemotherapy as neoadjuvant therapy, and then continue with single-agent therapy as adjuvant treatment for adults at high risk of recurrence.Resectable Non-Small Cell Lung Cancer, expected to be approved in 2024 Q3;（JXSS2300013）
Used forMSI-H/dMMR Advanced Endometrial CancerPatients who experience disease progression after systemic therapy in any setting and are not candidates for curative surgery or radiotherapy.Expected to be approved in 2024 Q3;（JXSS2300083）
High-riskAdjuvant and Neoadjuvant Therapy for Early-Stage ER+/HER2- Breast Cancer，Expected to be approved in Q4 2024；（JXSS2300085）
In combination with Venetoclax forFirst-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma(la/mUC) Adult Patients, expected to be approved in Q4 2024;（JXSS2400033）
Concurrent chemoradiotherapy (Cisplatin-based concurrent external beam radiation therapy followed by brachytherapy)For the radical treatment of high-risk, locally advanced cervical cancer (LACC), expected to be approved in Q4 2024;（JXSS2400034）
Combined with chemotherapy forFirst-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma，Expected to be approved in 2025 Q3；（JXSS2400071）

Image Source:Insight Database

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