FDA Approval Makes Breyanzi Third CAR-T Therapy in NHL
With the FDA’s approval of Bristol Myers Squibb’s (BMS) Breyanzi (lisocabtagene maraleucel) last month, there are now three chimeric antigen receptor T cell (CAR-T) therapies to treat a certain type of non-Hodgkin’s lymphoma (NHL). A Zitter Insights poll shows that payers do not anticipate its approval as having much of an impact on their management of the space. However, with more of these therapies in the pipeline, payers should take a closer look at these therapies and their management of them, say industry experts.
On Feb. 5, the FDA approved Breyanzi for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B (see brief, p. 8). The agency gave the CD19-directed CAR-T therapy orphan drug, regenerative medicine advanced therapy and breakthrough therapy designations.