Regeneron secures EU approval for bispecific lymphoma drug

Regeneron Pharmaceuticals has received authorization from the European Commission for its dual-acting drug odronextamab, marketed as Ordspono, to treat two types of lymphoma. This approval permits the use of Ordspono in 27 European Union countries for patients who have already undergone two or more lines of systemic therapy, including cell therapies.

Ordspono's journey to approval is supported by promising results from Phase 2 clinical trials. These trials demonstrated that the drug led to partial or complete responses in 80% of patients with follicular lymphoma and about 50% of those with diffuse large B cell lymphoma. This level of efficacy indicates a significant therapeutic potential for patients suffering from these forms of lymphoma.

Regeneron has been aiming for approval from the U.S. Food and Drug Administration (FDA) based on similar trial data. However, the FDA has required additional progress in confirmatory trials to substantiate the Phase 2 results before granting approval. Regeneron has not yet indicated when it plans to resubmit its application to the FDA.

This European approval marks a significant milestone for Regeneron as Ordspono becomes the company's first bispecific antibody drug. Bispecific antibodies are an emerging class of treatments that target two different molecules simultaneously, one on tumor cells and another on immune cells, to stimulate an immune attack on cancer. This mechanism offers a novel approach compared to the more intricate and expensive CAR-T cell therapies traditionally used for blood cancers like lymphoma.

The FDA has already approved several bispecific antibody drugs for lymphoma, including Roche's Lunsumio for follicular lymphoma in 2022, and both Genmab and AbbVie's Epkinly and Roche's Columvi for diffuse large B cell lymphoma in 2023. Unlike CAR-T therapies, which are personalized and derived from the patient's own cells, bispecific antibodies provide an off-the-shelf treatment option. However, while CAR-T therapies are typically administered in a single dose, bispecific antibodies necessitate repeated treatments, often involving lengthy infusions at healthcare facilities. Both therapy types have been associated with immune-related side effects that can require hospitalization.

Ordspono joins Regeneron's oncology portfolio alongside Libtayo, a drug for lung and skin cancer that generated $561 million in sales during the first half of 2024. Analysts like TD Cowen's Tyler Van Buren predict that Ordspono could substantially contribute to Regeneron's revenue, estimating it could reach $800 million in annual sales by 2035. Van Buren believes that a larger portion of these revenues will come from treating follicular lymphoma, given the drug's higher effectiveness in this condition.

The FDA's initial rejection of Ordspono's accelerated approval was not due to concerns about the drug's efficacy or safety. Instead, the agency focused on the enrollment status of the confirmatory studies required to validate the Phase 2 results. The FDA has been tightening its accelerated approval regulations in recent years to ensure that conditional approvals are confirmed through follow-up studies.