Tisagenlecleucel for Acute Lymphoblastic Leukemia
The FDA granted regular approval to tisagenlecleucel (Kymriah, Novartis) for the treatment of ALL that is refractory or in relapse in patients up to age 25.1 Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell immunotherapy agent. Efficacy Approval was based on a single-arm trial of 63 pedi...
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| Veröffentlicht in: | Drug Topics 2017-11, Vol.161 (11), p.23-23 |
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| creator | Hone, Lisa M Liu, Jason |
| description | The FDA granted regular approval to tisagenlecleucel (Kymriah, Novartis) for the treatment of ALL that is refractory or in relapse in patients up to age 25.1 Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell immunotherapy agent. Efficacy Approval was based on a single-arm trial of 63 pediatric patients with precursor B-cell ALL.3 Patients received a single dose of tisagenlecleucel intravenously within 2 to 14 days following completion of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Safety The most common side effects include: cytokine-release syndrome (CRS) (79%), hypogammaglobulinemia (43%), infections (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), and bleeding disorders (31%). |
| format | Magazinearticle |
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Efficacy Approval was based on a single-arm trial of 63 pediatric patients with precursor B-cell ALL.3 Patients received a single dose of tisagenlecleucel intravenously within 2 to 14 days following completion of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Safety The most common side effects include: cytokine-release syndrome (CRS) (79%), hypogammaglobulinemia (43%), infections (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), and bleeding disorders (31%).</description><identifier>ISSN: 0012-6616</identifier><identifier>EISSN: 1937-8157</identifier><language>eng</language><publisher>Monmouth Junction: UBM LLC</publisher><subject>Acute lymphocytic leukemia ; Care and treatment ; Complications and side effects ; Cytokines ; Drug approval ; Drug dosages ; FDA approval ; Gene therapy ; Hypotension ; Infections ; Laws, regulations and rules ; Leukemia ; Patients ; Pharmaceutical industry ; Safety and security measures ; Tisagenlecleucel</subject><ispartof>Drug Topics, 2017-11, Vol.161 (11), p.23-23</ispartof><rights>COPYRIGHT 2017 UBM LLC</rights><rights>Copyright UBM Americas Nov 2017</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>313,781,785,792</link.rule.ids></links><search><creatorcontrib>Hone, Lisa M</creatorcontrib><creatorcontrib>Liu, Jason</creatorcontrib><title>Tisagenlecleucel for Acute Lymphoblastic Leukemia</title><title>Drug Topics</title><description>The FDA granted regular approval to tisagenlecleucel (Kymriah, Novartis) for the treatment of ALL that is refractory or in relapse in patients up to age 25.1 Tisagenlecleucel is a chimeric antigen receptor (CAR) T-cell immunotherapy agent. 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Efficacy Approval was based on a single-arm trial of 63 pediatric patients with precursor B-cell ALL.3 Patients received a single dose of tisagenlecleucel intravenously within 2 to 14 days following completion of lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Safety The most common side effects include: cytokine-release syndrome (CRS) (79%), hypogammaglobulinemia (43%), infections (41%), pyrexia (40%), decreased appetite (37%), headache (37%), encephalopathy (34%), hypotension (31%), and bleeding disorders (31%).</abstract><cop>Monmouth Junction</cop><pub>UBM LLC</pub><tpages>1</tpages></addata></record> |
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| language | eng |
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| subjects | Acute lymphocytic leukemia Care and treatment Complications and side effects Cytokines Drug approval Drug dosages FDA approval Gene therapy Hypotension Infections Laws, regulations and rules Leukemia Patients Pharmaceutical industry Safety and security measures Tisagenlecleucel |
| title | Tisagenlecleucel for Acute Lymphoblastic Leukemia |
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