Regeneron Pharmaceuticals Receives Positive Recommendation for Odronextamab for Treatment of Relapsed/Refractory Lymphomas
Regeneron Pharmaceuticals announced on Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending conditional approval of odronextamab for relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. This is a significant development as FL and DLBCL are two of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). It is estimated that approximately 120,000 FL cases and 163,000 DLBCL cases are diagnosed annually worldwide, with approximately 15,000 FL cases and 31,000 DLBCL cases diagnosed in Europe each year.
Understanding Relapsed/Refractory (R/R) Lymphomas
Relapsed/refractory (R/R) follicular lymphoma (FL) refers to cases where FL comes back after initial treatment (relapsed) or doesn’t respond to treatment (refractory). Similarly, R/R diffuse large B-cell lymphoma (DLBCL) occurs when DLBCL relapses or doesn’t respond to therapy. These types of lymphomas can be challenging to treat, especially when traditional treatments have failed.
The Role of Odronextamab in Treating R/R Lymphomas
The positive CHMP opinion regarding odronextamab is supported by results from the Phase 1 ELM-1 and Phase 2 ELM-2 trials. The trials demonstrated robust, durable response rates and an acceptable safety profile of odronextamab, making it a promising option for the treatment of R/R lymphomas. Regeneron is also evaluating the use of odronextamab as a monotherapy and in combination with other therapies across earlier lines of therapy in challenging-to-treat lymphomas.
The Development of OLYMPIA
The Phase 3 OLYMPIA development program is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs. Regeneron is testing the efficacy of odronextamab in combination with a costimulatory bispecific antibody, REGN5837 (CD22xCD28), and its cemiplimab for the treatment of R/R aggressive B-NHL in the ATHENA-1 and CLIO-1 studies, respectively.
Conclusion
Odronextamab has shown promise in treating relapsed/refractory lymphomas, especially in cases where traditional treatments have failed. With the positive CHMP opinion, this therapy could potentially become widely available for those in need. Further studies and development are ongoing, and Regeneron Pharmaceuticals continues to evaluate the use of odronextamab in combination with a range of other therapies.
Keywords:
- Regeneron Pharmaceuticals
- European Medicines Agency
- Odronextamab
- Relapsed/Refractory Lymphomas
- Follicular Lymphoma
- Diffuse Large B-cell Lymphoma
- B-cell Non-Hodgkin Lymphoma
- ELM-1
- ELM-2
- OLYMPIA development program
- REGN5837 (CD22xCD28)
- Cemiplimab
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