1. Dec 21, 2020

FDA approves selinexor for patients with previously treated multiple myeloma

The U.S. Food and Drug Administration has approved selinexor (Xpovio; Karyopharm Therapeutics Inc) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Selinexor was pervious approved for adults with relapsed or refractory multiple myeloma previously treated with at least 4 other therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

“New treatments for multiple myeloma remain a critical need for both patients and their treating physicians," said Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute and co-senior author of the BOSTON study publication, in a press release. "Selinexor with once weekly bortezomib-dexamethasone (SVd) demonstrated encouraging and highly significant results in the Phase 3 BOSTON study, including a 47% improvement in progression-free survival versus standard twice weekly bortezomib-dexamethasone (Vd). Patients receiving SVd had approximately 35% fewer clinic visits compared to those receiving the standard, twice-weekly Vd regimen, thus receiving 40% less bortezomib and 25% less dexamethasone as compared with the control arm in the first 24 weeks of therapy. This once-weekly dosing feature helps makes the SVd regimen attractively simple. Importantly, patients achieved a significantly higher overall response of 76% with once-weekly SVd compared with the standard control arm therapy, and higher response rates were observed regardless of prior therapies received, the presence of high-risk cytogenetics, renal impairment or advanced age. Finally, adverse events with SVd were important but generally self-limiting, reversible, and proved manageable with dose modifications and aggressive supportive care, as well as generating significantly lower rates of peripheral neuropathy compared to the control group. As the only approved nuclear export inhibitor that has demonstrated a strong synergistic effect with a proteasome inhibitor such as bortezomib, selinexor has, in my opinion, the potential to meet a current treatment gap for our multiple myeloma patients in need of new therapeutic options.”

Read the full press release here.