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Positive CHMP opinion for Keytruda + chemotherapy as first-line treatment for esophageal cancer or HER2-negative gastroesophageal junction adenocarcinoma.- Merck Inc.,

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Last updated:24th Sep 2021
Published:25th May 2021
Merck Inc., announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 10).

The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the second quarter of 2021. “Patients with metastatic esophageal cancer currently face five-year survival rates of just 5%,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “There is a critical need for new treatment options in the first-line setting that can potentially extend their lives. Today’s positive opinion for Keytruda is an important step forward for patients in Europe with certain types of gastrointestinal cancers.” The positive CHMP opinion is based on results from the pivotal Phase III KEYNOTE-590 trial, in which Keytruda plus 5-fluorouracil (5-FU) and cisplatin demonstrated significant improvements in overall survival and progression-free survival compared with 5-FU and cisplatin alone in patients regardless of histology or PD-L1 expression status. Keytruda plus 5-FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death by 35% (hr="0.65" [95% ci, 0.55-0.76]; p><0.0001) versus 5-fu and cisplatin alone.></0.0001)></0.0001)>

Condition: Oesophageal Cancer + Gastro Junction
Type: drug