FDA Grants Fast Track Designation to Selinexor to Treat Diffuse Large B-cell Lymphoma

The Food and Drug Administration (FDA) granted fast track designation to selinexor for the treatment of patients with diffuse large B-cell lymphoma (DLBCL), according to Karyopharm Therapeutics, the drug’s manufacturer.

“The receipt of fast track designation from the FDA for selinexor in relapsed DLBCL underscores the great unmet medical need for this aggressive form of lymphoma,” said Sharon Shacham, Ph.D., MBA, founder, president and chief scientific officer of Karyopharm, said in a press release.

Fast track designation from the FDA helps to facilitate the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs by expediting the drug's development, review and potential approval. In addition, this designation could allow for a drug to be eligible for accelerated approval or priority review, if the criteria for the new drug application submitted by the drug’s manufacturer are met.

Selinexor, a first in class, oral SINE compound, is currently being studied in the ongoing phase 2b SADAL study — designed to evaluate the agent in patients with DLBCL who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.

In the study, approximately 125 patients will receive 60 mg of oral selinexor twice weekly in four-week cycles. The primary endpoint of the study is objective response rate, while duration of response serves as the secondary endpoint.

The company noted these top-line results will be presented at the upcoming American Society of Hematology (ASH) 2018 Annual Meeting, held Dec. 1-4, in San Diego.

“Pending positive results from the phase 2b SADAL study, we plan to submit a second (new drug application) to the FDA in the first half of 2019, with a request for accelerated approval, for oral selinexor as a potential new treatment for patients with relapsed or refractory DLBCL,” Shacham added.