Drugs

Karyopharm sNDA for Xpovio

Karyopharm Therapeutics has submitted a supplemental NDA for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma. The submission is based on data from the pivotal Phase 3 BOSTON study evaluating the combination of Xpovio (selinexor), once-weekly Velcade (Takeda’s bortezomib) and low-dose dexamethasone as a second line treatment for patients with relapsed or refractory multiple myeloma, the company says. The combination treatment “demonstrated a statistically significant reduction in the risk of disease progression or death, along with a 47% increase in median progression-free survival, as well as a significantly higher overall response rate, as compared to the standard Velcade and dexamethasone regimen,” it adds.

Xpovio works by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1), according to Karyopharm. It 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,” it says.

FDA granted accelerated approval for Xpovio 7/2019 in combination with dexamethasone for treating adult patients with relapsed refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome