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EU Application Filed for Daratumumab in Newly Diagnosed, Transplant-Eligible Myeloma

Gina Columbus @ginacolumbusonc
Published: Wednesday, Mar 27, 2019

Jan van de Winkel, PhD

Jan van de Winkel, PhD
A Type II variation application has been submitted to the European Medicines Agency for the 4-drug regimen of daratumumab (Darzalex), bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone as a treatment for patients with newly diagnosed multiple myeloma who are eligible to undergo autologous stem cell transplant (ASCT).1

This application announcement follows another sBLA submission, also in March 2019, for daratumumab in combination with lenalidomide (Revlimid) and dexamethasone as a treatment for patients with newly diagnosed multiple myeloma who are ineligible for ASCT.

References

  1. Genmab Announces European Regulatory Submission for Daratumumab in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma. Genmab. Published March 27, 2019. https://bit.ly/2V0o9rE. Accessed March 27, 2019.
  2. Genmab Announces Positive Topline Results in Phase III CASSIOPEIA Study of Daratumumab in Front Line Multiple Myeloma. Genmab. Published October 21, 2018. https://bit.ly/2WpwMvY. Accessed March 26, 2019.
  3. Janssen Submits Application for DARZALEX (daratumumab) Combination Therapy to U.S. FDA for Newly Diagnosed, Transplant Eligible Patients with Multiple Myeloma. Janssen. Published March 26, 2019. https://prn.to/2Ou6rue. Accessed March 26, 2019.

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