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2022-05-27| Trials & Approvals

Janssen’s First Cell Therapy Gets Europe’s Approval for Multiple Myeloma

by Fujie Tham
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Janssen’s first cell therapy – Carvykti, was granted conditional marketing authorization for treatment of adults with relapsed and refractory multiple myeloma (RRMM) by the European Commission (EC). The therapeutic developed jointly with China-based Legend Biotech was approved by the FDA earlier in February in the US.

Multiple myeloma is a rare cancer of blood plasma cells, a type of white blood cell that manufactures antibodies and is found in the bone marrow. In multiple myeloma, proliferation of plasma cells is unregulated, causing abnormal, immature plasma cells to multiply and fill up the bone marrow spaces. When plasma cells turn cancerous, they no longer protect the body and produce abnormal proteins that can cause issues affecting the kidneys, bones, or blood.

Related article: J&J, Legend’s Cell Therapy Gets FDA Nod 

Addressing Unmet Needs for New Multiple Myeloma Treatments

 

Carvykti’s active ingredient is ciltacabtagene autoleucel, a genetically modified autologous T cell immunotherapy consisting of modified T-cells bearing a chimeric antigen receptor (CAR) that targets B cell maturation antigen (BCMA). BCMA is expressed primarily on the surface of malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. Upon binding to BCMA-expressing cells, the CAR promotes T cell activation, expansion, and the elimination of cancerous cells.

As there is no cure for multiple myeloma, there is an urgent demand for Carvykti. Patients who already received immunomodulatory agents, proteasome inhibitors, and monoclonal antibodies, have recurring disease, or stopped responding to previous treatments can now be treated with a different approach. 

The pharma giant projected peak annual sales of Carvykti to exceed $5 billion. Based on a deal inked in 2017, Johnson & Johnson and Legend will divide the profits 30-70 in China and 50-50 in all other countries. Carvykti is currently under review in Japan, while Legend Biotech secured a breakthrough therapy designation in China, the first product to be granted such a label.

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