The FDA has approved selinexor for relapsed or refractory diffuse large B-cell lymphoma, according to a press release.
The new approval is for adult patients who previously received at least two lines of systemic therapy. The manufacturer also noted that the approval was for patients with DLBCL that was not otherwise specified, including follicular lymphoma that transformed into DLBCL.
Oral Selinexor is a “Selective Inhibitor of Nuclear Export (SINE) compound,” according to the manufacturer.
The new indication was approved under the FDA’s Accelerated Approval program. Approval was based on results from the Phase 2b SADAL clinical trial. 134 study participants were administered 60 mg of selinexor twice weekly for 4 weeks.
The overall response rate was 29%, with a 13% complete response rate. Additionally, the researchers observed a 16% partial response rate.
“The accelerated approval of oral [selinexor] in patients with relapsed or refractory DLBCL is a significant milestone for the patients and families who currently have limited treatment options available for their disease,” Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm, said in a press release. “This approval marks the first for an oral agent for patients with previously treated DLBCL and the first approval of any single drug for this highly aggressive type of lymphoma. and clinical development to today’s second FDA approval.”
The manufacturer noted that continued approval for this DLBCL indication could be contingent on further confirmatory trials.
“For the significant number of patients with relapsed or refractory DLBCL, there is an important need for new therapies for this particularly vulnerable patient population,” John P. Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, said in a press release. “Unfortunately, despite often multiple types of chemotherapy and targeted-drug combination therapy, many patients have disease which continues to progress.”
Selinexor is also FDA-approved for the treatment of multiple myeloma in combination with corticosteroid dexamethasone.
