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On March 29, local time, Incyte announced that the European Commission (EC) formally approved the listing application of the powerful FGFR kinase inhibitor Pemazyre (pemigatinib), which is mainly used for the treatment of already received treatment, FGFR2 fusion or rearrangement, and inoperable Resected locally advanced or metastatic cholangiocarcinoma (cholangiocarcinoma) patients.
This is another good news following the accelerated approval of Pemazyre as the world's first targeted therapy for advanced cholangiocarcinoma in the United States.
The approval of pemigatinib in the EU this time is an important milestone in the field of targeted therapy for cholangiocarcinoma.
It is the first new treatment plan for cholangiocarcinoma approved by the EU in recent years, and it may mark the end of the era of chemotherapy for nodal cholangiocarcinoma.
Cholangiocarcinoma is a highly malignant, second most common tumor in the liver derived from bile duct epithelial cells, accounting for 10%-20% of all primary liver malignancies.
In recent years, the incidence and mortality of cholangiocarcinoma have been increasing worldwide.
However, currently, the choice of clinical treatment options for cholangiocarcinoma is very limited.
Early patients undergo surgery and advanced patients undergo chemotherapy.
However, because cholangiocarcinoma lacks specific molecular targets and is prone to drug resistance, surgical resection is currently the only one.
It is possible to cure cholangiocarcinoma.
With the development of precision medicine, targeted drugs and immune drugs have gradually entered the public's field of vision.
A large number of studies have found that FGFR (fibroblast growth factor receptor), as a typical type of receptor tyrosine kinases (RTKs), can be expressed on the cell membrane and stimulated and activated by extracellular signals.
Therefore, FGFR is involved in the occurrence of tumors.
And the role in development has gradually attracted the attention of scientists.It is worth mentioning that, so far, only Johnson & Johnson’s “Balversa” and Incyte’s “pemigatinib” have been approved by the US Food and Drug Administration (FDA) to selectively inhibit FGFR globally.
In 2019, the oral pan-FGFR inhibitor Balversa developed by Johnson & Johnson's Janssen became the world's first targeted therapy for metastatic bladder cancer, and it was also the world's first FGFR targeted drug approved for marketing.
In April last year, "pemigatinib", as the world's first targeted therapy for advanced cholangiocarcinoma, was quickly approved for marketing in the United States.
Previously, the drug had obtained breakthrough therapy designation, orphan drug designation, and priority review qualifications granted by the FDA.
The European Commission’s decision is based on a phase II clinical data called "FIGHT-202".
The study recruited 108 patients.
After 21 days of oral administration of 13.
5 mg of Pemazyre, the overall response rate (ORR) of the participants was ) Is 37%.
In terms of adverse reactions, on the one hand, the drug may cause hyponatremia in patients; on the other hand, it may increase the blood creatinine of pregnant women and affect the health of the fetus.
At the moment, FGFR has become a hot research field in the industry, and it is also one of the targets of "unlimited cancer" therapy.
In addition to the two FGFR inhibitors that have been approved for listing globally, large pharmaceutical companies such as Johnson & Johnson and Pfizer, as well as many Chinese innovations such as Nuocheng Jianhua, Cinda Bio, CStone Pharmaceuticals, Zai Lab, Hutchison Pharmaceuticals, etc.
Pharmaceutical companies are developing FGFR targeted therapies.
Among them, Pfizer's recombinant human FGFR3 bait protein candidate "TA-46" is expected to become a potential "first-in-class" biological agent for the treatment of achondroplasia. End Reference: [1] -Treatment-for-Adults-with-Locally-Advanced-or-Metastatic-Cholangiocarcinoma-with-a-Fibroblast-Growth-Factor-Receptor-2-FGFR2-Fusion-or-Rearrangement
This is another good news following the accelerated approval of Pemazyre as the world's first targeted therapy for advanced cholangiocarcinoma in the United States.
The approval of pemigatinib in the EU this time is an important milestone in the field of targeted therapy for cholangiocarcinoma.
It is the first new treatment plan for cholangiocarcinoma approved by the EU in recent years, and it may mark the end of the era of chemotherapy for nodal cholangiocarcinoma.
Cholangiocarcinoma is a highly malignant, second most common tumor in the liver derived from bile duct epithelial cells, accounting for 10%-20% of all primary liver malignancies.
In recent years, the incidence and mortality of cholangiocarcinoma have been increasing worldwide.
However, currently, the choice of clinical treatment options for cholangiocarcinoma is very limited.
Early patients undergo surgery and advanced patients undergo chemotherapy.
However, because cholangiocarcinoma lacks specific molecular targets and is prone to drug resistance, surgical resection is currently the only one.
It is possible to cure cholangiocarcinoma.
With the development of precision medicine, targeted drugs and immune drugs have gradually entered the public's field of vision.
A large number of studies have found that FGFR (fibroblast growth factor receptor), as a typical type of receptor tyrosine kinases (RTKs), can be expressed on the cell membrane and stimulated and activated by extracellular signals.
Therefore, FGFR is involved in the occurrence of tumors.
And the role in development has gradually attracted the attention of scientists.It is worth mentioning that, so far, only Johnson & Johnson’s “Balversa” and Incyte’s “pemigatinib” have been approved by the US Food and Drug Administration (FDA) to selectively inhibit FGFR globally.
In 2019, the oral pan-FGFR inhibitor Balversa developed by Johnson & Johnson's Janssen became the world's first targeted therapy for metastatic bladder cancer, and it was also the world's first FGFR targeted drug approved for marketing.
In April last year, "pemigatinib", as the world's first targeted therapy for advanced cholangiocarcinoma, was quickly approved for marketing in the United States.
Previously, the drug had obtained breakthrough therapy designation, orphan drug designation, and priority review qualifications granted by the FDA.
The European Commission’s decision is based on a phase II clinical data called "FIGHT-202".
The study recruited 108 patients.
After 21 days of oral administration of 13.
5 mg of Pemazyre, the overall response rate (ORR) of the participants was ) Is 37%.
In terms of adverse reactions, on the one hand, the drug may cause hyponatremia in patients; on the other hand, it may increase the blood creatinine of pregnant women and affect the health of the fetus.
At the moment, FGFR has become a hot research field in the industry, and it is also one of the targets of "unlimited cancer" therapy.
In addition to the two FGFR inhibitors that have been approved for listing globally, large pharmaceutical companies such as Johnson & Johnson and Pfizer, as well as many Chinese innovations such as Nuocheng Jianhua, Cinda Bio, CStone Pharmaceuticals, Zai Lab, Hutchison Pharmaceuticals, etc.
Pharmaceutical companies are developing FGFR targeted therapies.
Among them, Pfizer's recombinant human FGFR3 bait protein candidate "TA-46" is expected to become a potential "first-in-class" biological agent for the treatment of achondroplasia. End Reference: [1] -Treatment-for-Adults-with-Locally-Advanced-or-Metastatic-Cholangiocarcinoma-with-a-Fibroblast-Growth-Factor-Receptor-2-FGFR2-Fusion-or-Rearrangement
