Dr. Martin on Selinexor in Penta-Refractory Patients With Myeloma

Thomas G. Martin, MD
Published: Monday, Jan 14, 2019



Thomas G. Martin, MD, clinical professor of medicine, Adult Leukemia and Bone Marrow Transplantation Program, associate director, Myeloma Program, University of California, San Francisco (UCSF); co-leader, Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center, discusses the potential of selinexor in penta-refractory patients with multiple myeloma.

Patients who are penta-refractory tend to have very poor outcomes, says Martin. They have very aggressive disease and very limited therapeutic options available. Only about 10% of patients respond to therapy at this stage, Martin adds, and if patients do respond, it is for a limited duration of time of 3 months or less. However, selinexor has shown promise among this patient population. By inhibiting tumor suppressor proteins, selinexor tries to make cancer cells act normally.

In October 2018, the FDA granted a priority review to a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the application by April 6, 2019. The NDA is based on findings from the phase IIb STORM trial, which indicated an overall response rate of 26.2% with selinexor when added to dexamethasone.
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Thomas G. Martin, MD, clinical professor of medicine, Adult Leukemia and Bone Marrow Transplantation Program, associate director, Myeloma Program, University of California, San Francisco (UCSF); co-leader, Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center, discusses the potential of selinexor in penta-refractory patients with multiple myeloma.

Patients who are penta-refractory tend to have very poor outcomes, says Martin. They have very aggressive disease and very limited therapeutic options available. Only about 10% of patients respond to therapy at this stage, Martin adds, and if patients do respond, it is for a limited duration of time of 3 months or less. However, selinexor has shown promise among this patient population. By inhibiting tumor suppressor proteins, selinexor tries to make cancer cells act normally.

In October 2018, the FDA granted a priority review to a new drug application (NDA) for selinexor for the treatment of patients with penta-refractory multiple myeloma. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the application by April 6, 2019. The NDA is based on findings from the phase IIb STORM trial, which indicated an overall response rate of 26.2% with selinexor when added to dexamethasone.



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