Patients eligible for transplant

EMA approves quadruplet combination of dara-VTd for newly diagnosed, transplant-eligible multiple myeloma

The European Medicines Agency (EMA) has approved a marketing extension for daratumumab (dara), meaning it can now be used for the treatment of patients with newly diagnosed multiple myeloma (NDMM), who are eligible for stem cell transplant (SCT), in combination with bortezomib (V), thalidomide (T), and dexamethasone (d; dara-VTd).1,2 The decision comes after the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the quadruplet combination in December 2019.3 Dara-VTd was previously approved for use in the US by the Food & Drug Administration (FDA) in September 2019.4

These approvals are based on Part 1 of the results of the CASSIOPEIA trial, presented during the American Society of Clinical Oncology (ASCO) meeting in 2019.5 CASSIOPEIA is a phase III trial comparing dara-VTd to VTd alone in patients with NDMM who are eligible for SCT. Based on the data presented at the ASCO meeting, the authors concluded that dara-VTd provided a significant clinical benefit over VTd, reducing the risk of progression or death by 53%. Additionally, the safety profile was consistent with each of the drugs individually and in established combinations.5 Part 2 of the trial is ongoing, with patients who achieve a response to induction and consolidation being re-randomized to maintenance with daratumumab (16mg/kg every eight weeks for up to two years), or observation. The primary endpoint of Part 2 is post-maintenance progression-free survival.6

References
  1. Pharmaphorum. Janssen’s Darzalex approved in EU for newly-diagnosed multiple myeloma. https://pharmaphorum.com/news/janssens-darzalex-approved-in-eu-for-multiple-myeloma/. Published 2020 Jan 21. [Accessed 2020 Jan 27]
  2. European Medicines Agency. EPAR, Darzalex. https://www.ema.europa.eu/en/documents/overview/darzalex-epar-medicine-overview_en.pdf. Published (updated) 2020 Jan. [Accessed 2020 Jan 27]
  3. European Medicines Agency. Darzalex. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/darzalex-0. Published 2019 Dec 12. [Accessed 2020 Jan 27]
  4. Healio. FDA approves Darzalex-based combination for first-line multiple myeloma treatment. https://www.healio.com/hematology-oncology/myeloma/news/online/%7Bd8139b99-2bbd-4a55-8d27-10549d392456%7D/fda-approves-darzalex-based-combination-for-first-line-multiple-myeloma-treatment. Published 2019 Sep 26. [Accessed 2020 Jan 27]
  5. Moreau P. et al. Phase 3 randomized study of daratumumab + bortezomib/thalidomide/dexamethasone (D-VTd) vs VTd in transplant-eligible newly diagnosed multiple myeloma: CASSIOPEIA Part 1 results. 2019 Jun 2. Oral Abstract #8003American Society of Clinical Oncology Annual Meeting 2019, Chicago, US
  6. ClinicalTrials.gov. A study to evaluate daratumumab in transplant eligible participants with previously untreated multiple myeloma (Cassiopeia). https://clinicaltrials.gov/ct2/show/NCT02541383. Updated 2019 Oct 29. [Accessed 2020 Jan 27]
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