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Janssen files sNDA for daratumumab in Japan
1/10/2019

Janssen Pharmaceuticals has filed a supplemental new drug application with Japanese regulators to approve Darzalex, or daratumumab, in combination with the standard of care -- which consists of Velcade, or bortezomib; melphalan; and prednisone -- to treat recently diagnosed multiple myeloma patients who are ineligible for a stem cell transplant. The same indication has already been approved for Darzalex in the US and EU.

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