GCC Recommendations

EMA Recommends Granting a Conditional Marketing Authorisation for Odronextamab

On June 27, 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended conditional marketing authorization for odronextamab (Ordspono) by Regeneron Ireland DAC. Ordspono, a bispecific antibody for infusion, targets follicular lymphoma and diffuse large B-cell lymphoma. It binds to CD20 on B cells and CD3 on T cells, activating T cells to destroy malignant B cells. A phase II study showed significant complete and overall response rates in relapsed or refractory patients. Common side effects include cytokine release syndrome, infections, and blood-related issues. Ordspono is intended for adults with relapsed or refractory lymphoma after two or more therapy lines and should be prescribed by experienced physicians. The full usage details will be in the summary of product characteristics. Conditional marketing authorization addresses unmet medical needs by allowing early access despite pending additional data. EMA will also review its orphan medicine designation.

Upfront FOLFOXIRI Plus Bevacizumab with or Without Atezolizumab for Patients with Metastatic Colorectal Cancer

The 4-year results from the ATEZOTRIBE trial, which treated metastatic colorectal cancer patients with first-line FOLFOXIRI plus bevacizumab, with or without atezolizumab, showed improved outcomes with the addition of atezolizumab. With a median follow-up of 45.2 months, median overall survival was 33.0 months with atezolizumab versus 27.2 months without. Patients with high tumor mutational burden and high Immunoscore Immune-Checkpoint tumors benefited more from atezolizumab. Overall, the addition of atezolizumab led to durable improvements in progression-free and overall survival.

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