-
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
Roche recently announced that the company has decided to voluntarily withdraw an accelerated approval from the United States: anti-PD-L1 therapy Tecentriq (generic name: atezolizumab, atezolizumab) combined with chemotherapy (Abraxane, albumin) Conjugated paclitaxel [nab-paclitaxel]) is used to treat adult patients with FDA-approved detection methods that confirm that tumors express PD-L1, unresectable, locally advanced or metastatic triple-negative breast cancer (mTNBC)
Roche made this decision after consulting the US Food and Drug Administration (FDA), based on the FDA's assessment of the current mTNBC treatment pattern, and in accordance with the requirements of the accelerated approval program
In March 2019, the US FDA accelerated the approval of Tecentriq for the treatment of mTNBC indications, making it the first immunotherapy approved under this situation
The FDA Oncology Drug Advisory Committee (ODAC) discussed the results of these two studies.
Roche will work with the FDA in the coming weeks to complete the withdrawal process
Tecentriq's extensive development projects include a number of ongoing and planned Phase 3 studies, covering lung cancer, genitourinary tract cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer, head and neck cancer and other cancer types
Tecentriq belongs to PD-(L)1 tumor immunotherapy, which targets the PD-L1 protein expressed on tumor cells and tumor infiltrating immune cells to block its interaction with PD-1 and B7.
As of now, Tecentriq has been approved by many countries as monotherapy and combined targeted therapy and/or chemotherapy to treat multiple types of cancer, including: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types metastatic urothelial carcinoma (mUC), PD-L1 positive triple negative breast cancer (TNBC), hepatocellular carcinoma (HCC), melanoma
Original source: Roche provides update on Tecentriq US indication for PD-L1-positive, metastatic triple-negative breast cancer
This article is from Bio Valley, for more information, please download the Bio Valley APP (http://
