Novartis submits second FDA application for CAR-T therapy Kymriah, this time in diffuse large B-cell

Following the "historic" FDA approval of the company’s CAR-T therapy Kymriah (tisagenlecleucel) in the treatment of paediatric and young adults with a form of acute lymphoblastic leukaemia just two months ago, Novartis has submitted a second marketing application for the therapy with the US regulator.

This time, the company is looking to secure approval for Kymriah in thetreatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). If approved, this would mean a second indication for the world’s first-ever FDA-approved CAR-T therapy.

Novartis is making this submission based on updated analysis of the Phase 2 JULIET trial in which Kymriah met its primary endpoint, with six-month data to be revealed in December this year.

"The approval of tisagenlecleucel in the treatment of children and young adults with second relapse or refractory B-cell ALL was a watershed moment in the journey for researchers to develop immunocellular therapies," explained Stephen Schuster, Director of the Lymphoma Program and Lymphoma Translational Research at the University of Pennsylvania Perelman School of Medicine. "The data show this therapy could change the treatment paradigm for patients with r/r DLBCL as we've seen durable complete responses in patients who previously relapsed or were refractory to prior therapies, and this second filing is a significant step toward realising its potential for even more patients who are currently battling fatal blood cancers."

Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer at Novartis, added: "Kymriah represents a historic breakthrough in the evolution of individualised immunotherapy and we are committed to bringing this innovation to as many patients who may benefit as possible. The response rates we've seen in the JULIET trial show that Kymriah has the potential to transform treatment for these patients and we look forward to collaborating with the FDA to make it available to patients for this second indication."

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for around 40% of all cases of the disease worldwide. Novartis plans to follow up its first two FDA marketing authorisations for Kymriah with applications in the same two indications with the European Medicines Agency later this year.