Saturday, 6 June 2020

European Commission Grants Marketing Authorisation for DARZALEX (daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted marketing authorisation for DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation­. In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to.



source https://www.pharmatutor.org/pharma-news/2020/european-commission-grants-marketing-authorisation-for-darzalex-daratumumab-subcutaneous-formulation-for-all-currently-approved-daratumumab-intravenous-formulation-indications

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