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FDA Approved for RRMM: Xpovio (selinexor) tablets + Velcade (Bortezomib) and Dexamethasone




On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.


FDA granted selinexor accelerated approval in 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who 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.


Efficacy of selinexor in combination with bortezomib and dexamethasone was evaluated in the BOSTON Trial (KCP-330-023, NCT03110562), a randomized (1:1) open-label, multicenter, active comparator-controlled trial in patients with RRMM who had previously received at least one and at most three prior therapies. Patients received once-weekly selinexor orally in combination with once-weekly bortezomib subcutaneous and low-dose dexamethasone twice-weekly orally (SVd) compared to the standard twice-weekly bortezomib plus low-dose dexamethasone (Vd).


 

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12/18/2020: FDA Approval








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