FDA grants priority review to Novartis' filing for CAR-T therapy CTL019

Novartis announced that the FDA granted priority review to the company's filing seeking approval of the CAR-T therapy CTL019 (tisagenlecleucel-T) in relapsed/refractory paediatric and young adults with B-cell acute lymphoblastic leukaemia (ALL). The drugmaker noted that this is its first submission for a CAR-T therapy.

"With CTL019, Novartis is at the forefront of the science and development of immunocellular therapy as a potential new innovative approach to treating certain cancers where there are limited options," remarked chief medical officer Vas Narasimhan. CTL019 was developed by the University of Pennsylvania, with Novartis licensing worldwide rights to the therapy in 2012.

According to the drugmaker, the FDA submission is based on results from the ELIANA study, with data presented last year showing that 82 percent of patients with relapsed/refractory B-cell ALL who received CTL019 achieved complete remission or complete remission with incomplete blood count recovery at three months post-treatment. Findings also showed that 48 percent of patients in the study experienced grade 3 or 4 cytokine release syndrome, although no deaths occurred due to the complication.

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Novartis indicated that it plans further filings for CTL019 in the US and Europe later this year, including an application to the FDA for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Meanwhile, the company will also make submissions to the European Medicines Agency in relapsed/refractory B-cell ALL and relapsed/refractory DLBCL.

In February, Kite Pharma said that it plans to complete its rolling submission with the FDA by the end of the first quarter seeking approval of its CAR-T therapy axicabtagene ciloleucel for the treatment of patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. For related analysis, see Physician Views Poll Results: Oncologists provide broad support for Kite Pharma's CAR-T treatment axicabtagene ciloleucel based on new clinical data.

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