FDA News

FDA grants fast track designation to selinexor for penta-refractory myeloma

The FDA granted fast track designation to selinexor for treatment of certain patients with penta-refractory multiple myeloma, according to the agent’s manufacturer.

The designation applies to use of selinexor (KPT-330, Karyopharm Therapeutics) for patients who have received at least three prior lines of therapy, including regimens comprised of an alkylating agent; a glucocorticoid; the immunomodulatory drugs lenalidomide (Revlimid, Celgene) and pomalidomide (Pomalyst, Celgene); the proteasome inhibitors bortezomib (Velcade, Takeda/Millennium) and carfilzomib (Kyprolis, Amgen); and the anti-CD38 monoclonal antibody daratumumab (Darzalex, Janssen).

Eligible patients must have disease refractory to at least one proteasome inhibitor, at least one immunomodulatory drug, daratumumab, glucocorticoids and their most recent anti-myeloma therapy.

Selinexor is a first-in-class, oral selective inhibitor of nuclear export compound. The drug binds with and inhibits the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. The goal of treatment is selective induction of apoptosis in cancer cells, while sparing healthy cells.

The FDA based the fast track designation on results of the multicenter, single-arm, phase 2b STORM study, which included 122 patients with heavily pretreated penta-refractory myeloma.

Patients received 80 mg oral selinexor twice weekly plus 20 mg low-dose dexamethasone twice weekly.

Overall response rate served as the primary endpoint. Secondary endpoints included duration of response and clinical benefit rate.

Topline data likely will be released at the end of this month, according to a Karyopharm Therapeutics-issued press release.

“The designation of fast track for selinexor represents important recognition by the FDA of the potential of this anticancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies,” Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm, said in the release. “We are fully committed to working closely with the FDA as we continue development of this potential new, orally administered treatment for patients who currently have no other treatment options of proven benefit.”

The FDA granted fast track designation to selinexor for treatment of certain patients with penta-refractory multiple myeloma, according to the agent’s manufacturer.

The designation applies to use of selinexor (KPT-330, Karyopharm Therapeutics) for patients who have received at least three prior lines of therapy, including regimens comprised of an alkylating agent; a glucocorticoid; the immunomodulatory drugs lenalidomide (Revlimid, Celgene) and pomalidomide (Pomalyst, Celgene); the proteasome inhibitors bortezomib (Velcade, Takeda/Millennium) and carfilzomib (Kyprolis, Amgen); and the anti-CD38 monoclonal antibody daratumumab (Darzalex, Janssen).

Eligible patients must have disease refractory to at least one proteasome inhibitor, at least one immunomodulatory drug, daratumumab, glucocorticoids and their most recent anti-myeloma therapy.

Selinexor is a first-in-class, oral selective inhibitor of nuclear export compound. The drug binds with and inhibits the nuclear export protein XPO1, leading to the accumulation of tumor suppressor proteins in the cell nucleus. The goal of treatment is selective induction of apoptosis in cancer cells, while sparing healthy cells.

The FDA based the fast track designation on results of the multicenter, single-arm, phase 2b STORM study, which included 122 patients with heavily pretreated penta-refractory myeloma.

Patients received 80 mg oral selinexor twice weekly plus 20 mg low-dose dexamethasone twice weekly.

Overall response rate served as the primary endpoint. Secondary endpoints included duration of response and clinical benefit rate.

Topline data likely will be released at the end of this month, according to a Karyopharm Therapeutics-issued press release.

“The designation of fast track for selinexor represents important recognition by the FDA of the potential of this anticancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies,” Sharon Shacham, PhD, MBA, founder, president and chief scientific officer of Karyopharm, said in the release. “We are fully committed to working closely with the FDA as we continue development of this potential new, orally administered treatment for patients who currently have no other treatment options of proven benefit.”