Novartis seeks FDA approval of CAR-T cell therapy Kymriah in diffuse large B-cell lymphoma

Novartis announced Tuesday that it submitted a filing to the FDA seeking approval of Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. In August, Kymriah became the first available CAR-T cell therapy when it received clearance in the US for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice.

According to Novartis, the latest filing is based on findings from the Phase II JULIET study. Results from the trial demonstrated a three-month overall response rate of 45 percent, with 37 percent of patients achieving a complete response and 8 percent achieving a partial response. Novartis added that the submission includes six-month data from the study, which will be presented at the American Society of Hematology (ASH) annual meeting later this year.

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"The response rates we've seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients," commented Vas Narasimhan, the company's head of drug development. Novartis plans to submit filings in Europe seeking approval of Kymriah, formerly known as CTL019, in both DLBCL and paediatric ALL later this year. The one-time treatment has been priced at $475 000 in the US for use in patients with ALL.

Earlier in October, Gilead Sciences' recently acquired Kite unit gained FDA approval for its CAR-T therapy Yescarta (axicabtagene ciloleucel) for certain patients with large B-cell lymphoma. The immunotherapy, which has been priced at $373 000, is indicated for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic treatment, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

For related analysis, see ViewPoints: Novartis filing brings CAR-T competition a step closer, and ViewPoints: And so it begins- Gilead's CAR-T approval sets off the cell therapy race.

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