In May 2018, Novartis received U.S. Food and Drug Administration (FDA) approval for Kymriah for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

Novartis’ Kymriah, approved in August 2017 was developed in collaboration with University of Pennsylvania, is the first personalized CAR T cell therapy by the FDA for treating B-ALL, and was further approved in May 2018 for the treatment of adult B-Cell lymphoma. Kymriah is the only CAR-T cell therapy available in the market to have FDA approvals of two different indications in B-cell ALL and non-Hodgkin lymphoma. Kymriah is one-time personalized immunocellular therapy manufactured by patients own T cells. In January 2018, Novartis received an accelerated assessment status to Marketing Authorization Application (MAA) for Kymriah by European Medicines Agency (EMA).

Analyst View:

Immunotherapy is touted to bear significant potential in treating patients with chemotherapy-resistant blood malignancies and solid tumors. The approval of Kymriah for non-hodgkin lymphoma and B-ALL would drive the market for CAR-T cell therapy. Kite Pharma, Inc. received U.S. FDA approval for Yescarta in October 2017, for the B cell lymphoma and certain types of non-Hodgkin lymphoma. This makes the CAR-T cell therapy market space highly competitive. Pharma giants are collaborating or merging with niche biotechnology companies specializing in CAR-T cell therapy development. Novartis was one of the first companies to venture into the commercial partnership with University of Pennsylvania, the US in the year 2012 for development of CAR-T cell therapy. Novartis also collaborated with Centers for Medicare and Medicaid Services (CMS) on the development of various value-based pricing models and schemes. This would make Kymriah more accessible and cost-effective as CAR-T cell therapy is highly priced.