Novartis said on Tuesday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah suspension for intravenous infusion, formerly CTL019, for adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who can’t get for autologous stem cell transplant (ASCT).
Only about 25% of patients with r/r DLBCL are eligible for ASCT, the mainstay of secondary treatment. If left untreated, r/r DLBCL has a life expectancy of three to four months.
In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah. In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approva. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer, said Novartis.
Vas Narasimhan, Chief Medical Officer, Novartis, said: “Kymriah represents a historic breakthrough in the evolution of individualized 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.”
Novartis plans to submit an application for marketing authorization with the European Medicines Agency (EMA) in both DLBCL and pediatric ALL later this year.
Stephen Schuster, director of the Lymphoma Program and Lymphoma Translational Research, University of Pennsylvania Perelman School of Medicine, said: “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. 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 realizing its potential for even more patients who are currently battling fatal blood cancers.”
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