Kymriah, the world's first CAR-T product, receives priority review for its new indication

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)
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In addition, the agency also granted priority review of the application
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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
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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
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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
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Kymriah is a CAR-T (Chimeric Antigen Receptor T Cell) immune cell therapy, jointly developed by the University of Pennsylvania and Novartis
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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
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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
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This international trial enrolled patients from more than 30 locations in 12 countries/regions around the world
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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)
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Importantly, in the ELARA trial, no patient developed Kymriah-related grade 3 or higher cytokine release syndrome within the first 8 weeks after infusion
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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)
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In addition, Novartis also submitted an application for this indication to the European Medicines Agency
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The European Commission has awarded Kymriah the title of orphan drug for the treatment of relapsed or refractory follicular lymphoma
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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
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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
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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
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According to statistics from Yigu, more than 40 CAR-T therapies are currently in clinical trials
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