Merck Receives Positive CHMP Opinion for KEYTRUDA® as First-Line Treatment for Persistent, Recurrent or Metastatic Cervical Cancer in the EU
MSD
Pharmaceutical R&D and Manufacturer
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Compiled by Draven
Recently, based on the positive results of the Phase 3 KEYNOTE-826 trial, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of MSD's anti-cancer drug Keytruda in combination with platinum-based chemotherapy for the treatment of persistent, recurrent, or metastatic cervical cancer in adults. The CHMP's recommendation will be reviewed by the European Commission, with an approval decision expected in the second quarter of this year.
As early as October 13, 2021, based on the results of the KEYNOTE-826 study at that time, the FDA approved the Keytruda regimen for first-line treatment of patients with persistent, recurrent, or metastatic cervical cancer. KEYNOTE-826 is a randomized, triple-blind, Phase 3 trial that enrolled a total of 617 patients to evaluate the efficacy and safety of Keytruda in combination with platinum-based chemotherapy (with or without bevacizumab) for first-line treatment of adult patients with persistent, recurrent, or metastatic cervical cancer.
The trial results showed that, compared with the placebo + platinum-based chemotherapy in the control group, K drug + platinum-based chemotherapy significantly improved the overall survival (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (HR=0.62 [95% CI, 0.50-0.77]; P<0.0001) of cervical cancer patients. In addition, the objective response rate (ORR) of the Keytruda regimen was higher than that of the control group, with rates of 50% (95% CI, 44-56) and 68% (95% CI, 62-74), respectively.
For a long time, platinum-based chemotherapy (with or without bevacizumab) has been the first-line standard treatment for advanced and metastatic cervical cancer. Keytruda, MSD's重磅抗癌药, was approved for marketing by the FDA on September 4, 2014, and received approval from the European Medicines Agency on July 17, 2015. It is marketed by MSD in the United States and Europe.
It is worth mentioning that Keytruda has currently been approved by the FDA for indications involving multiple types of cancers, including melanoma, small cell lung cancer, non-small cell lung cancer, squamous cell carcinoma of the head and neck, classical Hodgkin lymphoma, urothelial carcinoma, non-muscle-invasive bladder cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, renal cell carcinoma, endometrial cancer, cutaneous squamous cell carcinoma, triple-negative breast cancer, and primary mediastinal large B-cell lymphoma.
Reference Source:
Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
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