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Broadened marketing authorisation for Darzalex in multiple myeloma recommended

Janssen-Cilag International NV has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Darzalex®▼ (daratumumab).

If approved by the European Commission, daratumumab can be used in combination with lenalidomide and dexamethasone; or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.1

Despite the incredible work of the oncology community over the past decade, MM remains an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.2

The Positive Opinion of the CHMP was based on a review of data from the Phase III MMY3003 (POLLUX) study, published in The New England Journal of Medicinein October 2016,3 and the Phase III MMY3004 (CASTOR) study, also published in The New England Journal of Medicine in August 2016.4

The safety profile of daratumumab in combination with standard-of-care regimens was consistent with monotherapy studies. In combination with lenalidomide, and dexamethasone (POLLUX) the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).3 Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2.3 In combination with bortezomib and dexamethasone (CASTOR) three of the most common grade 3 or 4 adverse events reported were thrombocytopenia (45.3%), anaemia (14.4%), and neutropenia (12.8%).4 Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of patients), and in 98.2% of these patients, they occurred during the first infusion.4

This positive opinion recognises progress in the treatment of multiple myeloma and has the potential to offer new treatment options to eligible patients”, said Torben Plesner, MD, Vejle Hospital, Vejle, Denmark, a daratumumab clinical trial investigator. “Daratumumab has already demonstrated single-agent efficacy in highly refractory patients. Now, consistent with these data, the results when used in combination with standard-of-care regimens after one prior line of therapy are also encouraging.”

Daratumumab first received conditional approval from the European Commission (EC) in May 2016, indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.5,6 Daratumumab was the first CD38-directed monoclonal antibody approved for use worldwide.

Almost all patients with multiple myeloma have to endure relapses which typically become more aggressive,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa (EMEA). “I am heartened by this important and rapid recommendation which recognises the progress in multiple myeloma treatment.”

The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to grant approval of the new indication. This milestone follows last year’s decision by the US Food and Drug Administration  on 21 November 2016, to approve the expanded use of daratumumab in combination with bortezomib/dexamethasone or lenalidomide/dexamethasone in patients with multiple myeloma who have received at least one prior therapy.7


  1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017. Available at:…. Last accessed February 2017.
  2. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: Last accessed November 2016.
  3. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide and dexamethasone for multiple myeloma. New Eng J Med. 2016;375:1319–1331.
  4. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for relapsed and refractory multiple myeloma. New Eng J Med. 2016;375:754–766.
  5. Janssen. Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM). Available at:…. Last accessed November 2016.
  6. European Medicines Agency. DARZALEX summary of product characteristics, May 2016. Available at:… Last accessed August 2016.
  7. DARZALEX® Prescribing Information November 2016. Available at: Last accessed January 2016.