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FDA Approval Sought for Frontline Daratumumab in Myeloma

Jason M. Broderick @jasoncology
Published: Tuesday, Nov 21, 2017

multiple myeloma
A supplemental biologics license application (sBLA) has been submitted to the FDA for daratumumab (Darzalex) for use in combination with bortezomib (Velcade), melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

In June 2017, the FDA approved daratumumab for use in combination with pomalidomide (Pomalyst) and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide. The approval was based on data from the phase I EQUULEUS (MMY1001) trial, in which the ORR was 59% (95% CI, 49.1%-68.8%) with the daratumumab triplet in patients with relapsed/refractory myeloma.

References

  1. Lonial S, Weiss BM, Usmani SZ, et al. Phase II study of daratumumab (DARA) monotherapy in patients with ≥3 lines of prior therapy or double refractory multiple myeloma (MM): 54767414MMY2002 (Sirius). J Clin Oncol. 2015;33 (suppl; abstr LBA8512).
  2. Lokhorst HM, Plesner T, Laubach JP, et al. Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma [published online August 26, 2015]. N Engl J Med. doi: 10.1056/NEJMoa1506348.
  3. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(14):1319-1331.
  4. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2016;375(8):754-766.
  5. Genmab Announces U.S. FDA Approval of DARZALEX® (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma. Genmab. http://ir.genmab.com/releasedetail.cfm?ReleaseID=1030508. Accessed November 21, 2017.

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