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European Commission Approves Janssen’s Talvey


Bispecific therapy indicated for the treatment of relapsed and refractory multiple myeloma.

XXY pluripotent stem cells. generative ai 1. Image Credit: Adobe Stock Images/Floren Horcajo

Image Credit: Adobe Stock Images/Floren Horcajo

Janssen Pharmaceutical, a Johnson & Johnson (J&J) company, revealed the European Commission’s (EC) decision to grant the conditional marketing authorization (CMA) of Talvey for adults with relapsed and refractory multiple myeloma (RRMM). Specifically, patients will need to have previously received a minimum of three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy, according to a company press release.

Earlier this month, the FDA also approved Talvey for RRMM treatment.

“Today’s European Commission decision brings a new off-the-shelf option with a novel cellular target and the immediate option of biweekly dosing, to an area of high unmet clinical need,” said Edmond Chan, MBChB, MD, senior director EMEA therapeutic area lead haematology, Janssen-Cilag Limited, as per the aforementioned release. “The high overall response rates in patients with heavily pretreated multiple myeloma, including those with prior T-cell redirection therapy, are encouraging and we believe talquetamab has the potential to offer physicians flexibility and versatility when determining the optimal treatment regimen for their patients.”

Reference: European Commission Approves TALVEY®▼ (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma. Johnson & Johnson. August 22, 2023. Accessed August 22, 2023. https://www.jnj.com/european-commission-approves-talvey-talquetamab-janssens-novel-bispecific-therapy-for-the-treatment-of-patients-with-relapsed-and-refractory-multiple-myeloma

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