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Content source: Medical Valley Recently, Novartis announced that the U.
S.
Food and Drug Administration (FDA) has accepted its CAR-T product Kymriah (tisagenlecleucel) supplementary biologics license application (sBLA) for the treatment of relapsed or refractory (r /r) Adult patients with follicular lymphoma (FL)
.
In addition, the agency also granted priority review of the application
.
It is worth noting that, if approved, this will be the third indication for Novartis’ CAR-T cell therapy drug Kymriah granted by the FDA
.
According to the official website of the FDA, the FDA has shortened the review time of products granted priority review to within 6 months, which means that the new indication for follicular lymphoma, Kymriah, is expected to be approved in April 2022
.
Previously, in August 2017 and May 2018, Kymriah was approved to treat patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), respectively Patient
.
Kymriah is a CAR-T (Chimeric Antigen Receptor T Cell) immune cell therapy, jointly developed by the University of Pennsylvania and Novartis
.
The basic principle is to obtain the patient's own T cells, then modify and process them to have the ability to recognize and kill cancer cells, and then inject the processed T cells into the patient's body to treat cancer
.
This submission of sBLA is mainly based on a single-arm, multi-center, open-label Phase II clinical trial (ELARA) to study the efficacy and safety of Kymriah in adult patients with r/r FL after at least two previous treatments.
Sex
.
This international trial enrolled patients from more than 30 locations in 12 countries/regions around the world
.
The main analysis data published on ASCO 2021 showed that Kymriah responded to most patients receiving treatment, 66% achieved complete remission (95% CI, 56-75), and the overall response rate was 86% (95% CI, 78 -92)
.
Importantly, in the ELARA trial, no patient developed Kymriah-related grade 3 or higher cytokine release syndrome within the first 8 weeks after infusion
.
According to the preliminary results of the ELARA trial, in April this year, the FDA has awarded Kymriah the title of Regenerative Medicine Advanced Therapy (RMAT)
.
In addition, Novartis also submitted an application for this indication to the European Medicines Agency
.
The European Commission has awarded Kymriah the title of orphan drug for the treatment of relapsed or refractory follicular lymphoma
.
At present, Kymriah has been approved for listing in the United States, Japan, the European Union and Canada, and is also covered by medical insurance in Japan
.
Up to now, a total of 6 CAR-T cell therapies have been approved for the market worldwide, namely Novartis Kymriah, Yescarta and Tecartus of Gilead’s subsidiary Kite, Bristol-Myers Squibb Breyanzi, Celgene’s Abecma and WuXi Juno’s Ruiji Oronza injection
.
At the same time, in the context of globalization, more and more Chinese companies have joined the research and development of CAR-T therapy in this field, and the domestic cell therapy industry is showing a booming development trend
.
According to statistics from Yigu, more than 40 CAR-T therapies are currently in clinical trials
.
Disclaimer The articles reproduced on the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
S.
Food and Drug Administration (FDA) has accepted its CAR-T product Kymriah (tisagenlecleucel) supplementary biologics license application (sBLA) for the treatment of relapsed or refractory (r /r) Adult patients with follicular lymphoma (FL)
.
In addition, the agency also granted priority review of the application
.
It is worth noting that, if approved, this will be the third indication for Novartis’ CAR-T cell therapy drug Kymriah granted by the FDA
.
According to the official website of the FDA, the FDA has shortened the review time of products granted priority review to within 6 months, which means that the new indication for follicular lymphoma, Kymriah, is expected to be approved in April 2022
.
Previously, in August 2017 and May 2018, Kymriah was approved to treat patients with relapsed/refractory acute lymphoblastic leukemia (ALL) and adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), respectively Patient
.
Kymriah is a CAR-T (Chimeric Antigen Receptor T Cell) immune cell therapy, jointly developed by the University of Pennsylvania and Novartis
.
The basic principle is to obtain the patient's own T cells, then modify and process them to have the ability to recognize and kill cancer cells, and then inject the processed T cells into the patient's body to treat cancer
.
This submission of sBLA is mainly based on a single-arm, multi-center, open-label Phase II clinical trial (ELARA) to study the efficacy and safety of Kymriah in adult patients with r/r FL after at least two previous treatments.
Sex
.
This international trial enrolled patients from more than 30 locations in 12 countries/regions around the world
.
The main analysis data published on ASCO 2021 showed that Kymriah responded to most patients receiving treatment, 66% achieved complete remission (95% CI, 56-75), and the overall response rate was 86% (95% CI, 78 -92)
.
Importantly, in the ELARA trial, no patient developed Kymriah-related grade 3 or higher cytokine release syndrome within the first 8 weeks after infusion
.
According to the preliminary results of the ELARA trial, in April this year, the FDA has awarded Kymriah the title of Regenerative Medicine Advanced Therapy (RMAT)
.
In addition, Novartis also submitted an application for this indication to the European Medicines Agency
.
The European Commission has awarded Kymriah the title of orphan drug for the treatment of relapsed or refractory follicular lymphoma
.
At present, Kymriah has been approved for listing in the United States, Japan, the European Union and Canada, and is also covered by medical insurance in Japan
.
Up to now, a total of 6 CAR-T cell therapies have been approved for the market worldwide, namely Novartis Kymriah, Yescarta and Tecartus of Gilead’s subsidiary Kite, Bristol-Myers Squibb Breyanzi, Celgene’s Abecma and WuXi Juno’s Ruiji Oronza injection
.
At the same time, in the context of globalization, more and more Chinese companies have joined the research and development of CAR-T therapy in this field, and the domestic cell therapy industry is showing a booming development trend
.
According to statistics from Yigu, more than 40 CAR-T therapies are currently in clinical trials
.
Disclaimer The articles reproduced on the "Yaodu" official account are from other official account platforms, and the main purpose is to share industry-related knowledge and deliver the latest information
.
The copyrights of the pictures and articles belong to the original author.
If there is any infringement, please inform us in time.
We will delete the relevant information within 24 hours
.
