Karyopharm Submits Supplemental New Drug Application to the FDA for XPOVIO® (selinexor) Plus Ruxolitinib for Patients with Myelofibrosis
Karyopharm Therapeutics submitted a supplemental New Drug Application to the FDA seeking Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for the treatment of myelofibrosis. The submission is based on data from the Phase 3 SENTRY trial and includes a request for Priority Review, which, if granted, could result in a six-month review process.
Key figures
- Drug Name
- XPOVIO (selinexor)
- Phase Of Trial
- Phase 3
- Trial patients
- 353
- Eu myelofibrosis patients
- 19000
- Us myelofibrosis patients
- 20000
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