Merck Receives Positive CHMP Opinion for KEYTRUDA in Combination with Chemotherapy as First-Line Treatment for Esophageal Cancer and HER2-Negative GEJ Adenocarcinoma
MSD
Pharmaceutical R&D and Manufacturer
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.
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According to foreign media reports, on May 24, MSD announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of MSD’s anti-PD-1 therapy KEYTRUDA in combination with platinum- and fluoropyrimidine-based chemotherapy as first-line treatment for adult patients with unresectable or metastatic esophageal cancer, or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, with a final decision expected in the second quarter of 2021.
The CHMP's positive opinion is based on the results of the pivotal Phase 3 KEYNOTE-590 trial, a global, multicenter, randomized, double-blind, controlled Phase III clinical study that enrolled 749 treatment-naïve patients with unresectable locally advanced or metastatic esophageal cancer, including esophageal adenocarcinoma, esophageal squamous cell carcinoma (ESCC), or Siewert type I adenocarcinoma of the gastroesophageal junction.
In this trial, KEYTRUDA in combination with 5-fluorouracil (5-FU) and cisplatin significantly improved overall survival and progression-free survival compared with placebo in combination with 5-FU and cisplatin, regardless of histology or PD-L1 expression status. KEYTRUDA in combination with 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]) and reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.55-0.76]).
Reference: Merck Receives Positive EU CHMP Opinion for KEYTRUDA® (pembrolizumab) in Combination With Chemotherapy as First-Line Treatment for Certain Patients With Esophageal Cancer or HER2-Negative Gastroesophageal Junction (GEJ) Adenocarcinoma
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