FDA Approves Xpovio (selinexor) for Multiple Myeloma and DLBCL

Xpovio is a nuclear export inhibitor. It blocks exportin 1 (XPO1), leading to nuclear accumulation of tumor suppressor proteins and growth regulatory proteins, resulting in cell cycle arrest and apoptosis.

Xpovio is indicated in combination with bortezomib and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy. It is also indicated in combination with dexamethasone for adult patients with relapsed or 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. Additionally, Xpovio is indicated for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. This indication is approved under accelerated approval based on response rate.

For multiple myeloma in combination with bortezomib and dexamethasone (XVd), the recommended dosage of Xpovio is 100 mg taken orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity, with bortezomib 1.3 mg/m2 subcutaneously once weekly on Day 1 for 4 weeks followed by 1 week off, and dexamethasone 20 mg orally twice weekly on Days 1 and 2. For multiple myeloma in combination with dexamethasone (Xd), the recommended dosage is 80 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity, with dexamethasone 20 mg orally with each dose of Xpovio. For DLBCL, the recommended dosage is 60 mg taken orally on Days 1 and 3 of each week until disease progression or unacceptable toxicity. Monitor CBC with differential, standard blood chemistries, body weight, nutritional status, and volume status at baseline and during treatment. Provide prophylactic antiemetics and maintain adequate fluid and caloric intake. Dosage modifications for adverse reactions are provided in the label.

Trial data not available in label.

Not reported in label.

Xpovio provides a new treatment option for patients with multiple myeloma after prior therapy, including those with heavily pretreated relapsed/refractory disease. For DLBCL, it offers an option after at least 2 lines of systemic therapy under accelerated approval.