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Subcutaneous daratumumab receives positive opinion from EMA CHMP and approval from the FDA

May 4, 2020

On April 30, 2020, a new pharmaceutical form of daratumumab (dara) was granted a positive opinion by the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency (EMA) . 1This decision extends the market authorization of dara for the treatment of patients with multiple myeloma (MM) to include dara as a solution for subcutaneous (SC) injection (1,800 mg in 15 ml vial) into the abdomen.

This decision was shortly followed by the U.S. Food and Drug Administration (FDA) approval of dara and hyaluronidase-fihj for SC administration on May 1, 2020. The recommended dosing schedule is 1,800 mg dara plus 30,000 units hyaluronidase administered SC into the abdomen over ~3–5 minutes. 2

The new formulation is recommended by the EMA CHMP, and approved by the FDA, for the following indications:

  • Adult patients with newly diagnosed MM (NDMM) ineligible for autologous stem cell transplant (auto-SCT) in combination with
    • lenalidomide + dexamethasone (Rd) or
    • bortezomib, melphalan and prednisone (VMP)
  • Adult patients with MM who have received ≥ 1 prior therapy, in combination with
    • Rd or
    • bortezomib and dexamethasone (Vd)
  • As a monotherapy for adult patients with relapsed and refractory MM (RRMM), who have received
    • EMA: ≥ 1 proteasome inhibitor and ≥ 1 immunomodulatory agent, with progressive disease following most recent therapy
    • FDA: ≥ 3 prior therapies including ≥ 1 proteasome inhibitor and ≥ 1 immunomodulatory agent, or who are double refractory to a proteasome inhibitor (PI) and an Immunomodulatory imide drugs (IMiD®)

The EMA CHMP positive opinion also recommends dara-SC for adult patients with NDMM eligible for auto-SCT in combination with bortezomib, thalidomide and dexamethasone (VTd).

The COLUMBA trial ( NCT03277105 ) was a pivotal study in the establishment of dara-SC and uncovered that dara-SC was non-inferior to intravenous administration. Patients reported an improved experience with dara-SC, with fewer infusion related reactions . The MM Hub previously provided an article summarizing the key points from the COLUMBA trial, as presented at the 2019 Annual American Society of Clinical Oncology (ASCO) Meeting—read it here. The MM Hub also reviewed the results from the phase II PLEIADES trial  ( NCT03412565 ), which investigated the efficacy and safety of dara-SC when combined with standard MM regimens, such as VMP, in both NDMM and RRMM.

  1. EMA. Darzalex. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/darzalex-1. Published 2020. Accessed May 01, 2020.

  2. US FDA. FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma | FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma. Published 2020. Accessed May 4, 2020.