- Posted by ISPE Boston
- On July 11, 2019
Karyopharm Therapeutics has announced that the FDA has approved its drug Xpovio (selinexor) in combination with dexamethasone for the treatment of certain adult patients with relapsed or refractory multiple myeloma (RRMM). Approval was granted under the Accelerated Approval Program which was developed by the FDA to allow for expedited approval of drugs that treat serious conditions and fill an unmet medical need. A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency. Karyopharm expects Xpovio to become commercially available in the U.S. on or before July 10, 2019.
According to the National Cancer Institute (NCI), multiple myeloma is the second most common cancer of the blood in the U.S. with more than 32,000 new cases each year and over 130,000 patients living with the disease. Despite recent therapeutic advances, there is currently no cure and most patients’ disease will typically progress following treatment with currently available therapies. According to the NCI, nearly 13,000 deaths due to multiple myeloma are expected in the U.S. in 2019.
Xpovio is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound which functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). Xpovio blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.
Selinexor is also being studied in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and is being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications. (Source: Karyopharm Therapeutics Website, 03 July, 2019)