Home / Press Release / Novartis’ Kymriah Bags Second U.S. FDA Approval

Novartis’ Kymriah Bags Second U.S. FDA Approval

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.

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