Dr. Anderson on Recent FDA Approvals in Multiple Myeloma

Larry Anderson, MD, PhD
Published: Tuesday, Jan 21, 2020



Larry Anderson, MD, PhD, associate professor, Department of Internal Medicine, Division of Hematology/Oncology, Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, discusses recent FDA approvals in multiple myeloma.

In June 2019, the FDA approved the combination of daratumumab (Darzalex), lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The approval was based on results of the phase III MAIA trial which demonstrated a 44% reduction in the risk of disease progression or death with DRd compared with lenalidomide/dexamethasone (Rd) alone. Additionally, the median progression-free survival was not reached versus 31.9 months in the DRd and Rd arms, respectively.

In July 2019, selinexor (Xpovio), a first-in-class Selective Inhibitor of Nuclear Export, was granted accelerated approval by the FDA in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody.

The approval was based on findings from Part 2 of the phase II STORM trial which showed an overall response rate of 25.3% with the combination (95% CI, 16.4-36.0). Patients on selinexor may experience nausea. Preemptive management with an aggressive antiemetic can help improve the tolerability of the regimen, concludes Anderson.
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Larry Anderson, MD, PhD, associate professor, Department of Internal Medicine, Division of Hematology/Oncology, Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, discusses recent FDA approvals in multiple myeloma.

In June 2019, the FDA approved the combination of daratumumab (Darzalex), lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

The approval was based on results of the phase III MAIA trial which demonstrated a 44% reduction in the risk of disease progression or death with DRd compared with lenalidomide/dexamethasone (Rd) alone. Additionally, the median progression-free survival was not reached versus 31.9 months in the DRd and Rd arms, respectively.

In July 2019, selinexor (Xpovio), a first-in-class Selective Inhibitor of Nuclear Export, was granted accelerated approval by the FDA in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma whose disease is refractory to ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and a CD38-targeted monoclonal antibody.

The approval was based on findings from Part 2 of the phase II STORM trial which showed an overall response rate of 25.3% with the combination (95% CI, 16.4-36.0). Patients on selinexor may experience nausea. Preemptive management with an aggressive antiemetic can help improve the tolerability of the regimen, concludes Anderson.



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