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EMA marketing application authorization submitted for Kymriah® (tisagenlecleucel)
On 6th November 2017, Novartis announced in a press release that the company has submitted a marketing authorization application to the European Medicines Agency (EMA) for two indications for Kymriah® (tisagenlecleucel).
The two indications include; treatment of children and young adults with relapsed or refractory (R/R) B-cell acute lymphoblastic leukemia (ALL) and adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
The application follows data from the phase II, single arm, multicenter JULIET study (NCT02445248) aiming to assess the safety and efficacy of tisagenlecleucel in adult patients with R/R DLBCL. Professor Stephen Schuster, Director Lymphoma Program at Abramson Cancer Center, Philadelphia described the interim results of the trial in an interview with Lymphoma Hub at the International Conference on Malignant Lymphoma (ICML) 2017.
Kymriah® is currently approved by the U.S. food and drug administration (FDA) for patients up to 25 years old with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Novartis has also submitted a supplementary biologics license application to the FDA for Kymriah® for the treatment of adults with R/R DLBCL.