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Johnson & Johnson Myeloma Treatment Gets Approval Recommendation in Europe
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Johnson & Johnson Myeloma Treatment Gets Approval Recommendation in Europe
Oct 3, 2024 12:26 AM

02:09 PM EDT, 09/20/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) unit Janssen-Cilag International said Friday that European regulators recommended the approval of a type 2 variation for Darzalex subcutaneous, or SC, formulation to treat myeloma.

Darzalex, or daratumumab, attaches to a protein called CD38 and prevents the growth of tumor cells. It may also affect normal cells in the body, the company said.

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of daratumumab SC use with bortezomib, lenalidomide, and dexamethasone, for treating adults with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant, the company said.

The recommendation is backed by data from a quadruplet therapy study with daratumumab SC formulation in the frontline setting, the company added.

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