EU regulatory authorities granted conditional approval to Regeneron’s bispecific antibody odronextamab for two forms of lymphoma.
It’s Regeneron’s first bispecific antibody approval in the world after it has faced a series of challenges in developing this type of cancer drug.
The European Commission approved odronextamab for follicular lymphoma and diffuse large B cell lymphoma patients whose cancer had returned or progressed following two or more lines of prior therapy, the company announced Monday. The antibody treatment will be marketed as Ordspono.
In March, the FDA rejected the drug, citing the enrollment status of its confirmatory trial. Regeneron also announced last week that the FDA turned down its multiple myeloma bispecific over issues at a third-party manufacturer.
Ordspono targets two markers — an antigen known as CD20 that’s expressed at abnormally high amounts in lymphoma, and CD3 on T cells. The goal is to bring T cells and cancer cells together and elicit an immune response to kill the cancer cells.
In order to keep Ordspono on the market and convert the conditional approval into a standard one, Regeneron must produce additional clinical data.
The EU’s approval makes Ordspono the fourth CD20xCD3 bispecific on the European market, following Roche’s Lunsumio and Columvi, as well as AbbVie’s Tepkinly.
TD Cowen analyst Tyler Van Buren noted that the therapy “is certainly competitive in DLBCL, but its efficacy stands out from approved agents in [follicular lymphoma]. Odro also boasts a superior safety profile, albeit with a more complex dosing regimen.” TD Cowen analysts project $800 million in sales by 2035.
In clinical trials, 80% of patients with relapsed or refractory follicular lymphoma responded to treatment, with 73% seeing all signs of cancer disappear. In diffuse large B cell lymphoma, 52% of patients who hadn’t received CAR-T therapy responded to treatment, while 48% of those who previously received CAR-T therapy responded.
On safety, 54% of patients experienced cytokine release syndrome, a serious reaction to immunotherapies where the immune system overactivates. Patients also experienced lower-than-normal levels of white blood cell counts, fever and anemia.