A Priority Review supplemental New Drug Application for selinexor, a selective inhibitor of nuclear export, has been accepted for filing by the FDA, according to the manufacturer, Karyopharm Therapeutics, Inc, in a press release. The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.
1The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
The FDA has assigned a user fee goal date of June 23, 2020 under the Prescription Drug User-Fee Act (PDUFA). A Priority Review is granted if an agent provides significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition when compared to standard applications.
“We look forward to supporting the FDA through the review process for our second NDA for XPOVIO as there remains significant unmet medical need for patients whose DLBCL has relapsed or is refractory to multiple drug therapies,” Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm, said in a statement.
The agent selectively binds to and inhibits the nuclear export protein exportin 1, blocking tumor suppressor, growth regulatory, and anti-inflammatory proteins. This accumulation blocks the many oncogenic pathways that allow cancer cells to continue to grow and divide.
Historically, selinexor has received both Orphan Drug and Fast Track designations from the FDA for the treatment for patients with relapsed or refractory DLBCL, based on findings from the SADAL study that was highlighted in an oral presentation at the 2019 International Conference on Malignant Lymphoma (ICML) being held June 18-22, 2019, in Lugano, Switzerland.
Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized phase III study in combination with bortezomib (Velcade) and low-dose dexamethasone (NCT03110562), as a potential backbone therapy in combination with approved therapies (NCT02343042), in liposarcoma (NCT02606461) and in endometrial cancer (NCT03555422), among others.
Selinexor hasbeen approved for a previous indicationin patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody. The approval was based on results from the single-arm, open-label, phase II STORM trial, which enrolled 122 patients with pentra-refractory multiple myeloma.
US Food and Drug Administration accepts Karyopharm’s supplemental new drug application for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma [new release]. Karyopharm Therapeutics, Inc, Newton, Massachusetts. February 19, 2020.https://bit.ly/37Cu77u. Accessed February 19, 2020.