Production & Manufacturing
Process & Production

Novartis seeks FDA approval for second Kymriah indication

Published 02 November 2017

Novartis has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).

Kymriah is a novel immunocellular therapy and a one-time treaent that uses a patient's own T cells to fight cancer.

The submission is based on results from the Novartis-sponsored, global, multi-centre Phase II JULIET study (NCT02445248), the first global, multi-centre registration study for Kymriah in adult patients with r/r DLBCL. In April 2017, Novartis received Breakthrough Therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah.

Novartis plans to submit an additional application for marketing authorization for Kymriah with the European Medicines Agency (EMA) in both DLBCL and paediatric ALL later this year. Novartis plans additional regulatory filings for Kymriah outside the US and EU in 2018.

In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched 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.

Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.

As announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis CAR-T products.

Source: Company Press Release