2 Information about daratumumab

2 Information about daratumumab

Marketing authorisation indication

Daratumumab (Darzalex, Janssen-Cilag) has a marketing authorisation 'in combination with…bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy'.

Dosage in the marketing authorisation

Daratumumab 16 mg/kg body weight is administered by intravenous infusion every week for weeks 1 to 9, every 3 weeks for weeks 10 to 24 and every 4 weeks from week 25 onwards.

Bortezomib is administered by subcutaneous injection at a dose of 1.3 mg/m2 twice weekly on days 1, 4, 8 and 11 for 8×21‑day cycles.

Dexamethasone is administered orally at a dose of 80 mg weekly.


The company has a managed access agreement, which includes a commercial arrangement, for daratumumab.

There is also a commercial arrangement for bortezomib.

  • National Institute for Health and Care Excellence (NICE)