Janssen files combo multiple myeloma drug for EU approval

22 March 2019

Janssen Pharmaceutica has submitted a Type II variation application to the European Medicines Agency (EMA) for a combination therapy for multiple myeloma.

The application seeks to broaden the existing marketing authorization for Darzalex (daratumumab) to include use in combination with lenalidomide (Revlimid) and dexamethasone (Rd) as treatment for newly-diagnosed multiple myeloma patients who are not candidates for high dose chemotherapy and autologous stem cell transplant (ASCT).

Darzalex is marketed by Janssen, a US healthcare giant Johnson & Johnson’s (NYSE: JNJ) pharma company, under a licensing deal with Denmark’s biotech firm Genmab (OMX: GEN). The drug generated sales of $2.03 billion in 2018 in its current indications.

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