Regeneron’s Linvoseltamab Receives Positive Opinion from EMA for Relapsed and Refractory Multiple Myeloma
Tarrytown, NY, USA – Regeneron Pharmaceuticals, Inc. made a significant breakthrough in the treatment of multiple myeloma (MM) with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopting a positive opinion for the conditional marketing authorization of linvoseltamab. This recommendation is for adults with relapsed and refractory (R/R) MM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
What is Linvoseltamab?
Linvoseltamab is a bispecific antibody that binds to both CD3 on T-cells and BCMA on myeloma cells, thereby recruiting T-cells to attack the cancer cells. This novel approach to immunotherapy aims to enhance the body’s immune response and target the cancer cells directly.
Impact on Patients
For patients with R/R MM, the prognosis has been poor, with limited treatment options and a median survival of approximately five years. The positive opinion from EMA provides a glimmer of hope for those who have exhausted other therapeutic avenues. If approved, linvoseltamab will offer a new treatment option, potentially extending lives and improving quality of life for these patients.
Impact on the World
Multiple myeloma affects approximately 130,000 Europeans, and this positive opinion from the EMA signifies a potential advancement in the treatment landscape for this disease. The approval of linvoseltamab could set a precedent for other bispecific antibodies, furthering the development of immunotherapies for various cancers. This progress is a testament to the continued investment in research and development in the pharmaceutical industry.
Future Prospects
The European Commission is expected to announce a final decision in the coming months regarding the marketing authorization of linvoseltamab. Regeneron plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2025. If approved, linvoseltamab will be the first bispecific antibody to enter the market for the treatment of R/R MM, offering a new and innovative approach to cancer treatment.
- Regeneron’s linvoseltamab recommended for conditional marketing authorization by EMA
- Treatment for adults with R/R MM who have exhausted other therapeutic options
- Bispecific antibody targets CD3 on T-cells and BCMA on myeloma cells
- Positive opinion could set precedent for other bispecific antibodies
- European Commission to announce final decision in coming months
- Regeneron to submit BLA to FDA in H1 2025
In conclusion, the positive opinion from the EMA for the conditional marketing authorization of livoseltamab represents a significant step forward in the treatment of relapsed and refractory multiple myeloma. This novel approach to immunotherapy offers a beacon of hope for patients who have exhausted other therapeutic options and could pave the way for further advancements in cancer treatment. The potential impact on both individual patients and the world underscores the importance of continued investment in research and development in the pharmaceutical industry.
