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After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear Xpovio.
After positive Phase 3 trial results, Karyopharm Therapeutics expects FDA to clear its Xpovio to treat multiple myeloma.
The pharma maker evaluated once weekly Xpovio, its oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with once weekly bortezomib (Velcade) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received 1 to 3 prior lines of therapy.
The results, published in The Lancet, demonstrate that the once-weekly regimen of Xpovio and Velcade, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade and low-dose dexamethasone regimen (Vd), Karyopharm said in a press release.
Xpovio received accelerated FDA approval last year for patients with penta-refractory multiple myeloma, and its supplemental New Drug Application for Xpovio as a treatment for patients with multiple myeloma who have received one prior line of therapy has been accepted by the agency. It is assigned a PDUFA action date of March 19, 2021.
“We are working closely with the regulatory authorities in both the U.S. and Europe to make this potential new treatment option, with a completely novel mechanism of action, available to patients as quickly as possible, if approved,” said Sharon Shacham, PhD, president and chief scientific officer of Karyopharm.
The trial results were achieved despite the use of approximately 40% less Velcade, 25% less dexamethasone, and around 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm, Karyopharm said.
“Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment and patients who had either prior bortezomib or lenalidomide treatment," said Paul Richardson, MD, co-author of the Lancet article and clinical program leader and director of Clinical Research at the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute.
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