-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
▎MSD, editor of WuXi AppTec's content team, announced today that the US FDA has approved the label update of the anti-PD-1 therapy Keytruda for the first-line treatment of advanced urothelial cancer (bladder cancer)
.
The US FDA has converted this indication from accelerated approval to full approval
.
In addition, the indication was revised to be used for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) patients who are not suitable for any platinum-containing chemotherapy regimens
.
Previously, Keytruda is indicated for the treatment of locally advanced or mUC patients who are not suitable for cisplatin-containing chemotherapy and whose tumors express PD-L1 ([CPS]≥10), or are not suitable for any platinum-containing chemotherapy (regardless of PD-L1 status) Of patients
.
Based on the tumor remission rate and duration of remission, this indication has been granted accelerated approval
.
The subsequent phase 3 trial KEYNOTE-361 evaluated the effect of Keytruda as a single-agent therapy in combination with chemotherapy in the first-line treatment of patients with advanced or mUC who are suitable for platinum-containing chemotherapy
.
Compared with standard chemotherapy, Keytruda did not meet the pre-specified dual primary endpoint of overall survival or progression-free survival
.
The label update follows the U.
S.
FDA Oncology Drug Advisory Committee (ODAC) meeting held earlier this year as part of an accelerated approval evaluation for industry-wide failure to meet post-marketing requirements
.
Members voted (5-3) in favor of maintaining the accelerated approval of Keytruda's first-line bladder indication
.
Dr.
Scot Ebbinghaus, Vice President of Clinical Research at Merck Laboratories, said: “While the treatment landscape is constantly changing, certain newly diagnosed patients with advanced urothelial cancer who are not suitable for platinum-containing chemotherapy still have unmet needs
.
We continue to Keytruda We are confident in the role played by these patients, who have few other treatment options, and are working hard to advance research to help more patients with bladder cancer and other types of cancer
.
"Reference: [1] FDA Approves Updated Indication for Merck's KEYTRUDA ® (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer).
Retrieved August 31, 2021, from https:// Note: This article aims to introduce medical health research Progress is not a recommended treatment plan
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
.
The US FDA has converted this indication from accelerated approval to full approval
.
In addition, the indication was revised to be used for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) patients who are not suitable for any platinum-containing chemotherapy regimens
.
Previously, Keytruda is indicated for the treatment of locally advanced or mUC patients who are not suitable for cisplatin-containing chemotherapy and whose tumors express PD-L1 ([CPS]≥10), or are not suitable for any platinum-containing chemotherapy (regardless of PD-L1 status) Of patients
.
Based on the tumor remission rate and duration of remission, this indication has been granted accelerated approval
.
The subsequent phase 3 trial KEYNOTE-361 evaluated the effect of Keytruda as a single-agent therapy in combination with chemotherapy in the first-line treatment of patients with advanced or mUC who are suitable for platinum-containing chemotherapy
.
Compared with standard chemotherapy, Keytruda did not meet the pre-specified dual primary endpoint of overall survival or progression-free survival
.
The label update follows the U.
S.
FDA Oncology Drug Advisory Committee (ODAC) meeting held earlier this year as part of an accelerated approval evaluation for industry-wide failure to meet post-marketing requirements
.
Members voted (5-3) in favor of maintaining the accelerated approval of Keytruda's first-line bladder indication
.
Dr.
Scot Ebbinghaus, Vice President of Clinical Research at Merck Laboratories, said: “While the treatment landscape is constantly changing, certain newly diagnosed patients with advanced urothelial cancer who are not suitable for platinum-containing chemotherapy still have unmet needs
.
We continue to Keytruda We are confident in the role played by these patients, who have few other treatment options, and are working hard to advance research to help more patients with bladder cancer and other types of cancer
.
"Reference: [1] FDA Approves Updated Indication for Merck's KEYTRUDA ® (pembrolizumab) for Treatment of Certain Patients With Urothelial Carcinoma (Bladder Cancer).
Retrieved August 31, 2021, from https:// Note: This article aims to introduce medical health research Progress is not a recommended treatment plan
.
If you need guidance on the treatment plan, please go to a regular hospital for treatment
.
