publication date: Jul. 24, 2020

Drugs & Targets

FDA accepts Karyopharm’s sNDA for Xpovio as a treatment for multiple myeloma after at least one prior line of therapy

FDA has accepted Karyopharm Therapeutics Inc.’s supplemental New Drug Application seeking approval for Xpovio—its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy.

Karyopharm expects a decision from the FDA regarding this sNDA before the end of the first quarter of 2021.

“If approved, we believe XPOVIO will become an important new, oral, once-weekly treatment option, used in combination with once-weekly Velcade®, for patients with multiple myeloma after at least one prior line of therapy,” Sharon Shacham, founder, president and chief scientific officer of Karyopharm, said in a statement.

Xpovio was previously approved by FDA for treatment of patients with penta-refractory multiple myeloma and relapsed or refractory diffuse large B-cell lymphoma. The company also plans to submit a Marketing Authorization Application to the European Medicines Agency later this year for this same indication.

NCI, Karyopharm to conduct research on Xpovio

NCI’s Cancer Therapy Evaluation Program and Karyopharm Therapeutics Inc. have entered into a Cooperative Research and Development Agreement.

The CRADA will focus on advancing Xpovio (selinexor), the company’s first-in-class, oral selective inhibitor of nuclear export compound, which blocks the cellular protein XPO1.

XPO1 plays a key role in regulating the activity of tumor suppressor proteins and other oncoproteins relevant in cancer cell biology and cancer cell survival. XPO1 may be an important, novel target in the treatment of numerous cancer types. XPO1 is frequently overexpressed in both hematologic and solid tumors, and … Continue reading FDA accepts Karyopharm’s sNDA for Xpovio as a treatment for multiple myeloma after at least one prior line of therapy

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