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News on April 29, 2021 /bioon.
com" target="_blank">/ --Roche recently announced that the U.
S.
Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) voted in favor of 7 votes and 2 votes against it to support the maintenance of anti-PD-L1 therapy Tecentriq.
, Generic name: atezolizumab, atezolizumab ) an accelerated approval for the treatment of PD-L1 positive triple-negative bioon.
com/tags/%E4%B9%B3%E8%85%BA%E7%99%8C/">breast cancer (TNBC), specifically: Tecentriq combined chemotherapy (Abraxane, albumin-bound paclitaxel [nab-paclitaxel] ), which is used to treat patients with TNBC whose bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors express PD-L1, unresectable, locally advanced, or metastatic TNBC with a detection method approved by the bioon.
com/fda/" target="_blank">FDA .
bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">
bioon.com" target="_blank">/ --Roche recently announced that the U.
S.
Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) voted in favor of 7 votes and 2 votes against it to support the maintenance of anti-PD-L1 therapy Tecentriq.
, Generic name: atezolizumab, atezolizumab ) an accelerated approval for the treatment of PD-L1 positive triple-negative bioon.
com/tags/%E4%B9%B3%E8%85%BA%E7%99%8C/">breast cancer (TNBC), specifically: Tecentriq combined chemotherapy (Abraxane, albumin-bound paclitaxel [nab-paclitaxel] ), which is used to treat patients with TNBC whose bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumors express PD-L1, unresectable, locally advanced, or metastatic TNBC with a detection method approved by the bioon.
com/fda/" target="_blank">FDA .
bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">
com" target="_blank">bioon.
com/tags/%E4%B9%B3%E8%85%BA%E7%99%8C/">Breast Cancer bioon.
com/fda/" target="_blank">FDA bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
The ODAC bioon.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">meeting is part of the bioon.
com/fda/" target="_blank">FDA's industry-wide review of accelerated approval of bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology drugs .
The bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology drugs involved failed to meet the primary endpoint in confirmatory trials and have not yet received routine approval.
The Advisory Committee provides independent opinions and recommendations from external medical experts to the FDA, although these recommendations are not legally binding.
At present, the bioon.
com/fda/" target="_blank">FDA has not announced when it will make a final decision on this indication for Tecentriq.
bioon. com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">meeting is part of the bioon.
com/fda/" target="_blank">FDA's industry-wide review of accelerated approval of bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology drugs .
The bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">oncology drugs involved failed to meet the primary endpoint in confirmatory trials and have not yet received routine approval.
The Advisory Committee provides independent opinions and recommendations from external medical experts to the FDA, although these recommendations are not legally binding.
At present, the bioon.
com/fda/" target="_blank">FDA has not announced when it will make a final decision on this indication for Tecentriq.
com/tags/%E4%BC%9A%E8%AE%AE/" target="_blank">Meeting bioon.
com/fda/" target="_blank">FDA bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Oncology bioon.
com/fda/" target="_blank">FDA
Chief Medical Officer and Levi Garraway, MD, Roche's head of global product development, said: "triple negative breast cancer patients is almost no treatment options, which is why today the Advisory Committee to make a significant recognition of the importance of combination therapy Tecentriq decisions we thank.
bioon.
com/fda/" target="_blank">The FDA and ODAC Open dialogue and look forward to continued cooperation to improve the lives of breast cancer patients.
"
bioon. bioon.
com/fda/" target="_blank">The FDA and ODAC Open dialogue and look forward to continued cooperation to improve the lives of breast cancer patients.
"
com/fda/" target="_blank">FDA
In 1992, the bioon.
com/fda/" target="_blank">FDA established the "Accelerated App Roval Program", which allows conditional approval of a drug to market to address the significant unmet medical needs in the field of serious diseases, and has specific post-marketing requirements (PMR).
) To confirm the clinical benefits of the drug and convert it to routine approval.
As an accelerated channel for new drug R&D and review, the launch of this project has accelerated the launch of some new drugs to a large extent.
bioon. com/fda/" target="_blank">FDA established the "Accelerated App Roval Program", which allows conditional approval of a drug to market to address the significant unmet medical needs in the field of serious diseases, and has specific post-marketing requirements (PMR).
) To confirm the clinical benefits of the drug and convert it to routine approval.
As an accelerated channel for new drug R&D and review, the launch of this project has accelerated the launch of some new drugs to a large extent.
com/fda/" target="_blank">FDA app
Tecentriq was approved by the U.
S.
bioon.
com/fda/" target="_blank">FDA in March 2019 for the treatment of adult patients with PD-L1 positive, unresectable, locally advanced or metastatic TNBC.
The approval is based on the positive progression-free survival (PFS) results of the Passion130 study.
Whether to continue to approve this indication depends on the results of the IMpassion131 study, which is the post-marketing requirement (PMR) for this mTNBC indication.
Tecentriq was approved by the U. S.
bioon.
com/fda/" target="_blank">FDA in March 2019 for the treatment of adult patients with PD-L1 positive, unresectable, locally advanced or metastatic TNBC.
The approval is based on the positive progression-free survival (PFS) results of the Passion130 study.
Whether to continue to approve this indication depends on the results of the IMpassion131 study, which is the post-marketing requirement (PMR) for this mTNBC indication.
S.
bioon.
com/fda/" target="_blank">FDA in March 2019 for the treatment of adult patients with PD-L1 positive, unresectable, locally advanced or metastatic TNBC.
bioon.
com/fda/" target="_blank">FDA
However, the results showed that in the initial (first-line) treatment of PD-L1-positive mTNBC patients, the IMpassion131 study did not achieve the primary endpoint of improving PFS.
Since the clinically significant benefits shown in the Passion130 study still exist, Roche looks forward to continuing to work with the bioon.
com/fda/" target="_blank">FDA to determine the next steps for Tecentriq in this indication.
The IMpassion131 study did not reach the primary endpoint of improving PFS. Since the clinically significant benefits shown in the Passion130 study still exist, Roche looks forward to continuing to work with the bioon.
com/fda/" target="_blank">FDA to determine the next steps for Tecentriq in this indication.
bioon.
com/fda/" target="_blank">FDA
Roche remains committed to tracking science to better understand cancer, including which patients may benefit from immunotherapy.
Tecentriq has proven its transformative role in the field of high medical needs, and is the first drug of its kind to be approved to treat certain types of cancer that are particularly difficult to treat.
Tecentriq has proven its transformative role in the field of high medical needs, and is the first drug of its kind to be approved to treat certain types of cancer that are particularly difficult to treat.
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.
This includes studies evaluating Tecentriq alone or in combination with other drugs, as well as studies in metastatic, adjuvant therapy, and neoadjuvant therapy.
This includes studies evaluating Tecentriq alone or in combination with other drugs, as well as studies in metastatic, adjuvant therapy, and neoadjuvant therapy.
Breast cancer is the most common type of cancer in women, with more than 2 million cases diagnosed globally each year.
TNBC accounts for about 15%.
Compared with other types, TNBC is more common in women under 50.
TNBC specifically refers to breast cancer with negative expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2), which progresses rapidly and has a very poor prognosis, 5 years The survival rate is less than 15%.
TNBC is ineffective against hormone therapy and HER2 targeted therapy (such as Herceptin), and treatment options are very limited, mainly relying on chemotherapy.
Metastatic TNBC is one of the most aggressive and difficult to treat breast cancers.
Compared with other subtypes of breast cancer, metastatic TNBC progresses rapidly and has a shorter survival time.
TNBC accounts for about 15%.
Compared with other types, TNBC is more common in women under 50.
TNBC specifically refers to breast cancer with negative expression of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER-2), which progresses rapidly and has a very poor prognosis, 5 years The survival rate is less than 15%.
TNBC is ineffective against hormone therapy and HER2 targeted therapy (such as Herceptin), and treatment options are very limited, mainly relying on chemotherapy.
Metastatic TNBC is one of the most aggressive and difficult to treat breast cancers.
Compared with other subtypes of breast cancer, metastatic TNBC progresses rapidly and has a shorter survival time.
For the past 30 years, Roche has been advancing breast cancer research, with the goal of helping as many breast cancer patients as possible.
The company's targeted drugs Herceptin, Perjeta, Phesgo, Kadcyla, Tecentriq are continuing to change the treatment pattern of early and late HER2-positive breast cancer and TNBC.
Through clinical development projects, Roche hopes to bring new treatment combinations to breast cancer patients and ultimately improve the prognosis.
Targeted drugs Herceptin, Perjeta, Phesgo, Kadcyla, Tecentriq are continuing to change the treatment pattern of early and late HER2-positive breast cancer and TNBC. The company's targeted drugs Herceptin, Perjeta, Phesgo, Kadcyla, Tecentriq are continuing to change the treatment pattern of early and late HER2-positive breast cancer and TNBC.
Through clinical development projects, Roche hopes to bring new treatment combinations to breast cancer patients and ultimately improve the prognosis.
Tecentriq belongs to PD-(L)1 tumor immunotherapy, which targets the PD-L1 protein expressed on tumor cells and bioon.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor infiltrating immune cells to block its interaction with PD-1 and B7.
1 receptors.
By inhibiting PD-L1, Tecentriq can activate T cells.
bioon. com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">tumor infiltrating immune cells to block its interaction with PD-1 and B7.
1 receptors.
By inhibiting PD-L1, Tecentriq can activate T cells.
com/course_video/chang-fei-bian-ma-RNA-yu-zhong-liu959063.
html">Tumor
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), bioon.
com/course_video/ge-tian831892.
html">melanoma, etc.
()
bioon. com/course_video/ge-tian831892.
html">melanoma, etc.
()
com/course_video/ge-tian831892.
html">Melanoma
Original source: US bioon.
com/fda/" target="_blank">FDA Advisory Committee votes in favour of maintaining accelerated app roval of Roche's Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
bioon. com/fda/" target="_blank">FDA Advisory Committee votes in favour of maintaining accelerated app roval of Roche's Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer
com/fda/" target="_blank">FDA app
