EC approves Janssen's Talvey for RRMM

The European Commission (EC) has granted conditional marketing authorization (CMA) of Talvey (talquetamab), developed by Janssen Pharmaceuticals, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ).

Talvey is approved as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

“As multiple myeloma progresses and patients cycle through treatments, the disease becomes more difficult to treat and remission periods shorten,” said Dr Maria-Victoria Mateos, consultant physician, hematology, University Hospital of Salamanca. “Targeting GPRC5D has been shown to deliver deep responses, and unlike many other targets for multiple myeloma, its expression is limited on immune cells providing an important new approach to targeting this heterogenous disease,” she noted.