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Request for approval of daratumumab plus pomalidomide and dexamethasone submitted to EMA and FDA

Nov 16, 2020

On November 12, 2020, regulatory applications were submitted to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) requesting the approval of subcutaneous daratumumab in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of relapsed or refractory multiple myeloma (RRMM).

Positive topline results from the phase III APOLLO study provided the foundations for the submission. The D-Pd regimen containing the intravenous formulation of daratumumab was approved by the FDA in 2017 for the treatment of patients with RRMM following at least two prior therapies, including lenalidomide and a proteasome inhibitor.

The full results from the APOLLO study will be presented at the 62nd American Society of Hematology (ASH) Annual Meeting on December 6 (abstract #412).

  1. PharmiWeb/Janssen. Janssen submits applications in the EU and U.S. seeking approval of DARZALEX®▼ (daratumumab) subcutaneous formulation in combination with pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. Accessed Nov 13, 2020. Published Nov 13, 2020.