On March 10, 2017, the FDA put a hold on all Selinexor clinical trials from Karyopharm. According to the FDA, the hold was placed on the drug due to incomplete documentation related to serious adverse events associated with selinexor. The hold was NOT placed due to any information regarding patient deaths or safety profile information. New patient recruiting was halted although patients already in selinexor trials were allowed to continue on trial.
Karyopharm has amended their investigator's brochure and as of March 30, 2017, the hold has now been lifted. Patients can now continue to join clinical trials involving selinexor. To date, more than 1,900 patients have been treated with selinexor in clinical trials across a variety of cancers.
Selinexor is a SINE (Selective Inhibitor of Nuclear Export) that binds to and stops the nuclear export protein XP01. Selinexor helps accumulate tumor suppressor proteins in the cell nucleus which then amplifies tumor suppression.
Selinexor made a splash at last year's American Society of Hematology conference due to the significant impact it had for highly relapsed and refractory myeloma patients.
It is currently being tested in a clinical trial called the STORM trial with low dose dexamethasone. It will be tested with typical myeloma "backbone" therapies in the STOMP trial. A new Phase III study is planned using selinexor with bortezomib and low-dose dexamethasone in the BOSTON trial.
To find all myeloma clinical trials using selinexor, click here:
All Selinexor Clinical Trials
To learn more about the STORM trial, click here:
STORM Myeloma Clinical Trial
about the author
Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can help accelerate a cure by weighing in and participating in clinical research. Founder of Myeloma Crowd by HealthTree and the HealthTree Foundation.