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2022-07-22T15:54:01.000Z

Selinexor combined with Vd receives European marketing authorization for RRMM

Jul 22, 2022
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Learning objective: After reading this article, learners will be able to cite a new clinical development in relapsed/refractory MM

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Following the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) in May 2022,1 selinexor in combination with bortezomib and dexamethasone (SVd) has received European marketing authorization for the treatment of patients with relapsed/refractory multiple myeloma.2 This approval is been based on results from the randomized phase III BOSTON trial (NCT03110562), which were reported in the Lancet in November 20203 and previously discussed by the Multiple Myeloma Hub here.

Selinexor is an oral, first-in-class, exportin 1 (XPO1) inhibitor, which through the BOSTON trial has been shown to be safe and efficacious in the treatment of patients with relapsed/refractory multiple myeloma who have received 1–3 prior courses of treatment.2

With a total of 402 patients enrolled, the BOSTON trial met its primary endpoint and demonstrated that once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death when compared to standard twice-weekly bortezomib plus dexamethasone (Vd).3 The median progression-free survival in the SVd arm was 13.93 months compared with 9.46 months in the Vd arm (hazard ratio, 0.70; p = 0.0075).3 The most frequent Grade 3/4 adverse events seen with VRd treatment were thrombocytopenia, anemia, and fatigue. SVd was considered well-tolerated, with adverse events that were manageable and reversible.                      

  1. European Medicines Agency. Nexpovio. https://www.ema.europa.eu/en/medicines/human/summaries-opinion/nexpovio-0. Accessed Jul 22, 2022
  2. Karyopharm Therapeutics. Karyopharm and Menarini group receive full marketing authorisation from the European Commission for NEXPOVIO® (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy. https://investors.karyopharm.com/2022-07-21-Karyopharm-and-Menarini-Group-Receive-Full-Marketing-Authorisation-from-the-European-Commission-for-NEXPOVIO-R-selinexor-for-the-Treatment-of-Patients-with-Multiple-Myeloma-After-at-Least-One-Prior-Therapy. Published Jul 21, 2022. Accessed Jul 22, 2022.
  3. Grosicki S, Simonova M, Spick I, et al. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020;14;396(10262):1563-1573. DOI: 1016/S0140-6736(20)32292

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