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EC Grants Full Marketing Authorization to Selinexor for Relapsed Myeloma

B-Cell in MM

The European Commission (EC) has granted marketing authorization for selinexor, an oral exportin 1 inhibitor, in combination with once-weekly bortezomib and low-dose dexamethasone for the treatment of adults with multiple myeloma (MM) who have received at least one prior therapy. With this approval for the extension of the selinexor indication in the European Union, the Conditional Marketing Authorization is now converted to a full approval.

Selinexor works by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). Selinexor 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 EC approval follows a positive opinion on selinexor by the European Committee for Medicinal Products for Human Use in May 2022 based on the multicenter, randomized, phase III BOSTON study that evaluated 402 adults with relapsed or refractory MM who had received one to three prior lines of therapy.

Source: PR Newswire via Menarini Group, July 2022

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