Dr. Richardson Discusses the FDA Approval of Selinexor in Myeloma

Paul Richardson, MD
Published: Wednesday, Jul 03, 2019


Paul Richardson, MD, clinical program leader, director of clinical research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, RJ Corman Professor of Medicine, Harvard Medical School, discusses the FDA approval of selinexor (Xpovio) in multiple myeloma.

The has FDA granted an accelerated approval to selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody. Data from Part 2 of the multicenter, single-arm, open-label, phase II STORM trial served as the basis for the approval. Findings demonstrated an overall response rate (ORR) of 25.3% (95% CI, 16.4-36.0) as assessed by an Independent Review Committee. Further, the stringent complete response rate was 1%, the very good partial response rate was 5%, and the partial response rate was 19%.

Selinexor is a first-in-class oral agent that has a unique mechanism of action. The agent is likely to have a broad effect, especially in settings of unmet need, says Richardson. 
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Paul Richardson, MD, clinical program leader, director of clinical research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, RJ Corman Professor of Medicine, Harvard Medical School, discusses the FDA approval of selinexor (Xpovio) in multiple myeloma.

The has FDA granted an accelerated approval to selinexor in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received ≥4 prior therapies and whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody. Data from Part 2 of the multicenter, single-arm, open-label, phase II STORM trial served as the basis for the approval. Findings demonstrated an overall response rate (ORR) of 25.3% (95% CI, 16.4-36.0) as assessed by an Independent Review Committee. Further, the stringent complete response rate was 1%, the very good partial response rate was 5%, and the partial response rate was 19%.

Selinexor is a first-in-class oral agent that has a unique mechanism of action. The agent is likely to have a broad effect, especially in settings of unmet need, says Richardson. 



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