Express congratulations! Keytruda was approved by FDA today for the treatment of gastric cancer
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Last Update: 2017-09-25
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Source: Internet
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Author: User
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Source: Wuxi apptec 2017-09-25 today, MSD, a partner of Wuxi apptec group, announced that the US FDA has approved its heavyweight immunotherapy drug keytruda (pembrolizumab) for the treatment of patients with recurrent locally advanced or metastatic gastric / gastroesophageal junction adenocarcinoma, and the tumor expresses PD-L1 This is also the first FDA approved anti-PD-1 therapy in a specific population of gastric cancer patients Gastric cancer is a kind of cancer that occurs in gastric tissue Worldwide, gastric cancer is the fifth most common type of cancer and the third leading cause of cancer death There are 952000 new cases of gastric cancer in the world every year, resulting in about 723000 deaths It is estimated that more than 10000 people died of gastric cancer in the United States in 2017 We don't have many excellent treatments for this disease Cancer immunotherapy, represented by anti-PD-1 drugs, has achieved good results in the treatment of a variety of cancers These PD-1 pathway inhibitors can block the interaction between PD-1 and its ligands PD-L1 and PD-L2, and activate T cells to kill tumor In keytruda, for example, this anti-PD-1 antibody has been approved for the treatment of lung cancer, melanoma, bladder cancer and other cancers with great harm to human health In a clinical trial called keynote-059, new drug developers in MSD further evaluated the potential of keytruda in the treatment of gastric cancer The study recruited 259 patients who had received at least two previous systematic treatments, but the disease continued to progress In the trial, the patients were further treated with 200 mg of keytruda every three weeks The overall response rate (ORR) of keytruda was 13.3% (95% CI: 8.2, 20.0), among which the complete response rate (CR) was 1.4% and the partial response rate (PR) was 11.9% These data have been approved by FDA In May this year, keytruda's application for treatment of gastric cancer was qualified for priority review Four months later, the new drug was approved for market "Historically, patients with advanced gastric cancer have been very difficult to treat, and they also need new treatments," said Charles S of Yale cancer center "There is a very diverse population of patients with gastric or gastroesophageal junction adenocarcinoma who have been treated many times," Dr Fuchs said "The results of keynote-059 show that pembrolizumab has the potential to change the way we care for these patients with refractory diseases in the third-line treatment." Dr Roger M Perlmutter, President of Merck Research Laboratories (photo source: Merck), "keytruda is the first PD-1 checkpoint inhibitor approved in the United States for the treatment of treated advanced gastric cancer or gastric esophageal junction adenocarcinoma, which fills the gap in treatment," said Roger M., President of Merck Research Laboratories "This approval is another milestone, and it's keytruda's 10th new indication in just three years," said Dr Perlmutter This result further demonstrates our commitment to our patients and our progress in fighting multiple cancers " We congratulate keytruda on being approved for the treatment of gastric cancer, and wish immunotherapy can bring life changes to more patients!
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