Fast track approval for selinexor to treat multiple myelomaJuly 4, 2019
The US FDA has granted accelerated approval to selinexor (Xpovio) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM), Karyopharm Therapeutics said.
Selinexor is a first-in-class, oral selective inhibitor of nuclear export (SINE) compound. It binds and inhibits the nuclear export protein, XPO1, leading to the accumulation of tumour suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumour suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells.
“Today we approved a treatment under our accelerated approval programme that provides a treatment option for patients with multiple myeloma with no available therapy,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research in a statement.
Efficacy of selinexor was evaluated in 83 patients with RRMM who were treated with the drug in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3%. The median time to first response was four weeks, with a range of one to ten weeks. The median treatment trials eye treatments a cell treatment cure for breast cancer duration of response was 3.8 months. The efficacy evaluation was supported by additional information from an ongoing, randomized trial in patients with multiple myeloma.
The FDA granted Fast Track designation to the drug. Selinexor also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.