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22-Oct-2019

CHMP Grants Positive Opinion for Expanded Use of Janssen’s Darzalex®▼(daratumumab) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible

BEERSE, BELGIUM, 18 October 2019 – The Janssen Pharmaceutical Companies of Johnson & Johnson today 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) to include the use of daratumumab in combination with lenalidomide and dexamethasone (DRd) for patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT).

“As multiple myeloma can become more complex with each relapse, it is important that patients receive the latest treatment options with the goal of extending their first remission period,” said Professor Thierry Facon, M.D., Service des Maladies du Sang, Hôpital Claude

Huriez, Lille, France, and principal investigator of the MAIA study. “For newly diagnosed patients who are transplant ineligible, this regimen could be an important frontline therapy option and reinforces the consistent clinical profile of daratumumab.”

This Positive Opinion is based on results from the Phase 3 MAIA (MMY3008) study, published in The New England Journal of Medicine,[i] and presented at the 2018 American Society of Hematology (ASH) Annual Meeting.

Additional information about the MAIA study can be found at www.ClinicalTrials.gov  (NCT02252172).

“This recommendation marks an important step towards realising our ambition to improve outcomes for patients with multiple myeloma, right from diagnosis, especially for the majority of patients who are not eligible for transplant,” said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.

“Daratumumab has been used to treat more than 100,000 patients worldwide and we look forward to working with regulatory authorities to bring this important therapy to even more patients with multiple myeloma,” adds Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag France.

This Opinion will now be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

Professor Thierry Facon was the principal investigator in the MAIA study. He was not compensated for any media work.


[i] Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H. e. 2019 May 30;380(22):2104-15.

Editor Details

  • Company:
    • The Janssen Pharmaceutical Companies of Johnson & Johnson
  • Name:
    • The Janssen Pharmaceutical Companies of Johnson & Johnson
Last Updated: 22-Oct-2019