Karyopharm’s Xpovio (selinexor) Receives FDA’s Accelerated Approval for Relapsed/Refractory Multiple Myeloma

Shots:

• The accelerated approval is based P-IIb STORM study results assessing Xpovio (80mg) + dexamethasone (20mg) in 122 patients with RRMM, prior treated with 4 therapies with the refractory disease to at least two proteasome inhibitors, immunomodulatory agent and anti-CD38 mAb
• The P-II STORM resulted in 25.3% overall response rate (ORR) in the subgroup of 83 patients whose disease is refractory to bortezomib/carfilzomib/lenalidomide/pomalidomide and daratumumab with a median time of response as 4wks. & median duration of response as 3.8mos.
• Xpovio is an oral therapy that selectively inhibits nuclear export protein exportin 1 (XPO1) with its expected US availability on or before July 10’ 2019 and its MAA is currently under review by EMA

Click here to read full press release/ article | Ref: Karyopharm | Image: Karyopharm