Regeneron gains European approval for bispecific lymphoma drug

Dive Brief:

• The European Commission has authorized Regeneron’s dual-acting drug odronextamab to treat two types of lymphoma, clearing it for use in 27 European Union countries, the company said Monday. The drug, which will be sold as Ordspono, can be used following two or more lines of systemic therapy, including cell therapies.
• In Phase 2 clinical trials, Ordspono treatment led to partial or complete responses in 80% of people with follicular lymphoma who took it and in about half of those who had diffuse large B cell lymphoma, Regeneron said.
• Regeneron had sought to gain Food and Drug Administration approval on the basis of similar data, but the agency wanted to see more progress in trials meant to confirm the Phase 2 data and rejected Ordspono. The company hasn’t provided any update on when it intends to ask the FDA for approval again.

Dive Insight:

In winning European approval, Ordspono became Regeneron’s first “bispecific” antibody drug, a class that has been in the spotlight in recent years as an alternative to costly and cumbersome CAR-T cell therapies for blood cancers like lymphoma. The drugs simultaneously bind to molecules on tumor cells and immune cells to stimulate an immune response to cancer.

The FDA approved Roche’s Lunsumio in 2022 to treat follicular lymphoma. In 2023, the agency approved Genmab and AbbVie’s Epkinly and Roche’s Columvi to treat diffuse large B cell lymphoma.

Unlike CAR-T drugs, which must be manufactured from a patients’ own cells, the bispecific drugs offer an off-the-shelf treatment option. CAR-T drugs are typically given once, however, while bispecifics require people with lymphoma to return to healthcare facilities for repeat treatment, which can involve lengthy infusions. Both CAR-Ts and bispecific antibodies have resulted in immune-related side effects that can lead to hospitalizations.

In Regeneron’s oncology business, Ordspono joins the lung and skin cancer drug Libtayo, which recorded $561 million in sales through the first six months of 2024. TD Cowen analyst Tyler Van Buren thinks Ordspono could become a significant revenue contributor, forecasting $800 million in annual sales for the drug by 2035.

According to Van Buren, more of that revenue will come from treatment in follicular lymphoma because Ordspono offers better effectiveness in that condition.

The FDA’s decision to initially reject Ordspono’s accelerated application wasn’t based on any issue with its approvability, Regeneron said, but rather enrollment status in confirmatory studies that will compare it to a placebo. The FDA has sought to tighten up its accelerated approval status in recent years because of so called “dangling” approvals that haven’t been confirmed with follow-up studies.

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