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Recent popular reports from Yimaike ★ Nanjing · Big coffee gathered in May2021 Nucleic Acid Drug Development Forum Announcement Schedule ★ May Nanjing2021 Nucleic Acid Drug Development Forum is about to open April 26, 2021 / Yimai Ke News eMedClub News/--Recently, The US FDA has accelerated the approval of GlaxoSmithKline's (GSK) PD-1 monoclonal antibody Dostarlimab (Jemperli) for the treatment of relapsed or advanced endometrial cancer in adults with mismatch repair defects (dMMR) that have progressed or recurred after platinum-containing therapy patient.
Dostarlimab became the seventh PD-1 product approved by the US FDA.
On the same day, the European Commission also granted a conditional marketing license for Dostarlimab for the treatment of adult patients with mismatch repair defect (dMMR) recurrence or advanced endometrial cancer that progressed or recurred after platinum-containing therapy.
Dostarlimab is a humanized IgG4 antibody with high affinity to PD-1 and can effectively block the binding of PD-1 to its ligands PD-L1 and PD-L2.
Dostarlimab was originally jointly developed by Tesaro and AnaptysBio and screened from AnaptysBio's SHM technology platform.
It is a humanized antibody of IgG4 subtype.
At the end of 2018, after GSK bought Tesaro, Dostarlimab fell into GSK's hands.
Recommended reading: The PD-1 antibody purchased by GSK for US$5.
1 billion has obtained positive clinical research data and is expected to be approved by the FDA in the second half of this year.
Yimai Meng revealed that endometrial cancer is the most common gynecological malignant tumor in the United States and the sixth in women Large cancer is also the cancer with the highest dMMR rate among all tumor types.About 25% of endometrial cancer patients have DNA mismatch repair defects (dMMR).
According to reports in the literature, this proportion is even higher in patients who progress or relapse after platinum-containing chemotherapy.
For patients who progress after platinum-containing chemotherapy, there is currently no standard treatment plan, and Jemperli provides new treatment options for such patients.
The US FDA’s accelerated approval of Dostarlimab is based on GARNET clinical trial data.
The data shows that among 71 evaluable dMMR patients with advanced or recurrent endometrial cancer (A1), the ORR was 42.
3% (95% CI; 30.
6-54.
6), the complete response rate (CR) was 12.
7%, and the partial response rate (PR) was 29.
6%.
Among them, 93.
3% showed DOR for 6 months or longer.
In terms of safety, the most common adverse reactions (≥20%) are fatigue/fatigue (48%), nausea (30%), diarrhea (26%), anemia (24%) and constipation (20%).
The most common grade 3 or 4 adverse reactions (≥2%) are anemia and elevated transaminases.
The 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
Dostarlimab became the seventh PD-1 product approved by the US FDA.
On the same day, the European Commission also granted a conditional marketing license for Dostarlimab for the treatment of adult patients with mismatch repair defect (dMMR) recurrence or advanced endometrial cancer that progressed or recurred after platinum-containing therapy.
Dostarlimab is a humanized IgG4 antibody with high affinity to PD-1 and can effectively block the binding of PD-1 to its ligands PD-L1 and PD-L2.
Dostarlimab was originally jointly developed by Tesaro and AnaptysBio and screened from AnaptysBio's SHM technology platform.
It is a humanized antibody of IgG4 subtype.
At the end of 2018, after GSK bought Tesaro, Dostarlimab fell into GSK's hands.
Recommended reading: The PD-1 antibody purchased by GSK for US$5.
1 billion has obtained positive clinical research data and is expected to be approved by the FDA in the second half of this year.
Yimai Meng revealed that endometrial cancer is the most common gynecological malignant tumor in the United States and the sixth in women Large cancer is also the cancer with the highest dMMR rate among all tumor types.About 25% of endometrial cancer patients have DNA mismatch repair defects (dMMR).
According to reports in the literature, this proportion is even higher in patients who progress or relapse after platinum-containing chemotherapy.
For patients who progress after platinum-containing chemotherapy, there is currently no standard treatment plan, and Jemperli provides new treatment options for such patients.
The US FDA’s accelerated approval of Dostarlimab is based on GARNET clinical trial data.
The data shows that among 71 evaluable dMMR patients with advanced or recurrent endometrial cancer (A1), the ORR was 42.
3% (95% CI; 30.
6-54.
6), the complete response rate (CR) was 12.
7%, and the partial response rate (PR) was 29.
6%.
Among them, 93.
3% showed DOR for 6 months or longer.
In terms of safety, the most common adverse reactions (≥20%) are fatigue/fatigue (48%), nausea (30%), diarrhea (26%), anemia (24%) and constipation (20%).
The most common grade 3 or 4 adverse reactions (≥2%) are anemia and elevated transaminases.
The 2021 nucleic acid drug development forum will kick off in Nanjing from May 7th to 8th, 2021, to welcome the "new era of super drugs".
