EU Approves Regeneron Lymphoma Treatment

The European Commission has granted approval for Regeneron’s odronextamab, marketed as Ordspono, for treating adults with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after they have undergone two or more lines of systemic therapy. This marks the first global regulatory endorsement for Ordspono, which is a bispecific antibody designed to connect T-cells with lymphoma cells, thereby enhancing the immune response against cancer.

The approval of Ordspono is grounded on the outcomes of phase 1 and phase 2 clinical trials that indicated notable efficacy. In the case of follicular lymphoma, these trials revealed an impressive objective response rate (ORR) of 80%, with 73% of patients achieving a complete response. For diffuse large B-cell lymphoma, the ORR was reported at 52% in patients who had not received CAR-T therapy and 48% in those who had experienced disease progression following CAR-T therapy.

Ordspono offers a convenient off-the-shelf treatment option that can be administered in an outpatient setting, positioning it as a practical choice for patients and healthcare providers. This ease of administration is expected to enhance patient compliance and streamline the treatment process.

Regeneron is not resting on this approval but is actively continuing to explore the potential of Ordspono in ongoing clinical investigations. These studies aim to evaluate the drug’s efficacy in earlier stages of therapy and its effectiveness when used in combination with other treatment modalities. By expanding the scope of clinical trials, Regeneron hopes to establish a broader application for Ordspono, potentially benefiting a wider patient population.

This milestone approval by the European Commission signifies a significant advancement in the treatment options available for patients suffering from follicular lymphoma and diffuse large B-cell lymphoma. It reflects the promising outcomes of rigorous clinical testing and underscores the potential of bispecific antibodies in enhancing cancer treatment. As research progresses, further insights into the full capabilities of Ordspono are anticipated, potentially leading to improved patient outcomes in these challenging lymphoma types.

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