On December 18'th, 2020, the FDA granted approval to selinexor along with bortezomib and dexamethasone in order to treat adult patients with multiple myeloma who received at least 1 prior therapy.
Approval of this new triplet expands the uses for the oral SINE medication to the second-line setting.
Previously, the selinexor was approved in 2019 by the FDA in order to treat adult patients with relapsed/refractory multiple myeloma who have received at least 4-prior treatments and whose disease is refractory to at least 2-PIs, at least 2-immunomodulatory agents, and an anti-CD38 monoclonal antibody.
This approval of selinexor is based on efficacy findings from the BOSTON trial, which randomized patients 1:1 were given selinexor together with the bortezomib and low-dose dexamethasone (SVd) or standard bortezomib plus low-dose dexamethasone (Vd).
According to a statement by Paul Richardson, MD, clinical program leader and director of clinical research, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute and co-senior study author of the BOSTON trial,"New treatments for MM remain a critical need for patients as well as their treating physicians."
"As the only approved nuclear export inhibitor that has shown a promising synergistic effect with a PI such as bortezomib, selinexor has, in my perspective, the potential to meet a current treatment gap for our MM patients in need of new therapeutic options, "Paul Richardson added.
The primary efficacy funding measure was progression-free survival (PFS).
Median progression-free survival was estimated at 13.9 months (95% CI: 11.7, Not Estimable) for the triplet selinexor bortezomib and low-dose dexamethasone arm compared to 9.5 months (95% CI: 7.6, 10.8) for the bortezomib plus low-dose dexamethasone arm (estimated hazard ratio 0.70; 95% CI: 0.53, 0.93).
Certain common adverse events linked with this triplet therapy, occurring in ≥20 percent of patients, include fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, cataract, vomiting, and decreased weight.
“The adverse events associated with this triplet therapy were necessary but generally self-limiting, reversible, and proved manageable through dose modifications and appropriate supportive care, as well as generating significantly decreased rates of peripheral neuropathy in comparison to the control population,” Richardson noted.
Selinexor is also approved by FDA in order to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma, not otherwise specified, following at least 2-lines of systemic therapy.
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