FDA refuse to file BMS/bluebird bio’s CAR-T therapy
The FDA did not request additional clinical or non-clinical data
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Tag: CAR-T
Janssen’s CAR-T shows 100% response rate in multiple myeloma
Longer-term follow-up data from CARTITUDE-1 study show an overall response rate of 100% while 86% experienced a complete response
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Kite files second CAR-T therapy with US regulators
A submission in the EU is expected early next year
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CAR-T therapies shine at ASH
Janssen’s JNJ-4528 and BMS’ liso-cel show 100% response rates
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SMC says ‘no’ to Novartis’ Kymriah for adults with lymphoma
Adults with lymphoma will not be able to access Novartis’ CAR-T therapy Kymriah on the NHS in Scotland after cost-regulators rejected funding for the treatment in this setting.
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Kymriah gets NICE approval for DLBCL
The National Institute for Health and Care Excellence (NICE) has approved Novartis’ chimeric antigen receptor T-cell (CAR T-cell) therapy Kymriah for treatment of adults with diffuse large B-cell lymphoma (DLBCL).
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First children set to receive Novartis’ Kymriah
The first children to receive Novartis’ Kymriah – a ‘game-changing’ CAR-T therapy for cancer – will start treatment at Great Ormond Street Hospital in London this week, NHS England has announced.
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Gilead strikes deal with NHS England on Yescarta access
Gilead has struck a deal with NHS England that allows some adults with lymphoma access to its “game-changing” CAR-T therapy Yescarta.
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NICE rejects Novartis’ CAR-T Kymriah for adult lymphoma
The National Institute for Health and Care Excellence has turned down NHS funding for use of Novartis’ CAR-T therapy Kymriah in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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NHS England strikes deal with Novartis on Kymriah
Hospitals are gearing up to offer Novartis’ ground-breaking CAR-T therapy Kymriah to children with advanced leukaemia, after the drugmaker reached a deal with NHS England over its provision.
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EU approves first CAR-T therapies
European regulators have approved Novartis’ Kymriah and Gilead’s Yescarta, enabling patients to access CAR-T therapies across the region for the first time.
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CAR-T therapies leap towards EU approval
The stage has been set for approval of the first chimeric antigen T-cell therapies (CAR-T) in Europe, after Novartis’ Kymriah and Gilead’s Yescarta both won backing from the Committee for Medicinal Products for Human Use (CHMP).
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