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AEMPS authorises Hospital Clínic's CAR-T ARI-0001 for patients with acute lympho...

The Spanish Agency of Medicines and Medical Devices (AEMPS) has approved CAR-T ARI-0001, developed by Hospital Clínic, as an advanced therapy drug of non-industrial production for its use in patients over 25 years of age with lymphoblastic leukaemia that is resistant to conventional treatments. It is the first CAR-T developed entirely in Europe to be approved by a regulatory agency.

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Keytruda Closer to Expanded EU Approval for Pediatric Resistant Hodgkin’s Lympho...

Keytruda (pembrolizumab) has been recommended for approval in the European Union (EU) to treat adults and children, 3 years and older, with relapsed or refractory classical Hodgkin’s lymphoma (cHL) whose disease failed to respond to autologous stem cell transplant (ASCT) or who received at least two prior therapies when ineligible for ASCT.

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FDA approves cell-based gene therapy to treat adults with relapsed or refractory...

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

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Liso-Cel BLA for Relapsed/Refractory LBCL Remains Under FDA Review

The biologics license application for the CAR T-cell product lisocabtagene maraleucel in adult patients with relapsed/refractory large B-cell lymphoma following at least 2 previous therapies continues to be under regulatory review by the FDA, and a decision on the application has not yet been reached.

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Tecartus Recommended for EU Approval as CAR T-cell Therapy for Mantle Cell Lymph...

A committee of the European Medicines Agency (EMA) has recommended the conditional approval of Tecartus (brexucabtagene autoleucel) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

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