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Tisagenlecleucel Nears European Approval for DLBCL, ALL

Jason M. Broderick @jasoncology
Published: Friday, Jun 29, 2018

Carl June, MD

Carl June, MD

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of tisagenlecleucel (Kymriah) for the treatment of either adult patients with diffuse large B-cell lymphoma (DLBCL) that is relapsed or refractory after 2 or more lines of systemic therapy, or patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant, or in second or later relapse, according to Novartis, the manufacturer of the CAR T-cell therapy.

"We are excited to see that through our collaboration with Novartis, physicians in more countries around the world may be able to use this novel and innovative CAR-T cell therapy to improve the treatment outcomes for their patients," added June.

At the EHA Congress, Peter Borchmann MD, of the Department of Internal Medicine, University Hospital of Cologne in Cologne, Germany, discussed long-term results from the JULIET trial that were updated after an additional 8 months of follow-up since the last presentation of JULIET results at the 2017 ASH conference in December. JULIET is single-arm open-label global phase II trial (NCT02445248) of tisagenlecleucel in adult patients with relapse/refractory DLBCL, who were ineligible for or had failed autologous stem cell transplant (ASCT). 

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