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On March 23, local time, Merck & Co.
(MSD) announced that the US Food and Drug Administration (FDA) has approved its anti-PD-1 inhibitor Keytruda combined with fluorouracil (FU) and cisplatin for locally advanced or metastatic esophageal cancer Or the first-line treatment of gastroesophageal junction (GEJ) adenocarcinoma.
This is the world's first anti-PD-1 immune combination therapy approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of this patient group.
Esophageal cancer is a malignant tumor that occurs in the epithelial tissue of the esophagus, and its main subtypes are squamous cell carcinoma and adenocarcinoma.
According to the latest global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, there were 9.
96 million cancer deaths worldwide in 2020, of which 540,000 were esophageal cancer deaths, ranking sixth.
"Keytruda" is a humanized anti-PD-1 monoclonal antibody therapy.
It can block the binding of PD-1 receptors to PD-L1 and PD-L2 to improve the body's immune system's ability to detect and kill cancer cells.
In 2014, based on the "KEYNOTE-181 and KEYNOTE-180" clinical trials of 628 melanoma patients, the U.
S.
Food and Drug Administration (FDA) approved Keytruda for the first time for the treatment of advanced melanoma, and it has been approved for medicinal use since then It is used for the treatment of more than 20 indications such as lung cancer, head and neck cancer, stomach cancer, hepatocellular carcinoma, etc.
In 2019, the U.
S.
Food and Drug Administration (FDA) approved Keytruda for the second-line treatment of esophageal cancer, and it was successively marketed in China and Japan, which means that esophageal cancer therapy has officially entered the age of immunity.
Under the leadership of Keytruda, immunotherapies represented by PD-1/PD-L1 inhibitors have risen rapidly, and a variety of second-line immunotherapies for esophageal cancer have emerged, such as Bristol-Myers Squibb's (NYSE: BMY) nivolumab.
Monoclonal antibody) and Hengrui Medicine’s Karelizumab (Erica), among which nivolumab has been granted priority review by the U.
S.
Food and Drug Administration (FDA).
However, the first-line treatment for esophageal cancer is still in a blank stage, so it will be a milestone in the medical community to advance esophageal cancer immunotherapy from second-line treatment to first-line treatment.
The approved first-line treatment for esophageal cancer is based on data from a phase III KEYNOTE-590 trial (NCT03189719), which included a total of 749 patients with metastatic or locally advanced esophageal cancer.
The results of clinical trials showed that compared with fluorouracil (FU) and cisplatin alone, KEYTRUDA reduced the risk of death in patients with esophageal cancer by 27%, and the risk of disease progression and death by 35%.
Scientists' exploration in the field of esophageal cancer is far from stopping.
In the future, we look forward to more immunotherapies that can highlight the encirclement and bring good news to more and more patients.
End reference materials: [1]https://mp.
weixin.
qq.
com/s/KT0HxtzjcjoYMm4PDK4Mpg[2] -and-fluoropyrimidine-based-chemotherapy-for-treatment-of-certain-patients-with-locally-advanced-or-metastatic-esophageal-or-g/3.
[3] news/home/20210323005359/en