gdc
FDA Approvals, News & UpdatesMultiple Myeloma

Xpovio Approved for Patients with Relapsed or Refractory Multiple Myeloma

In December 2020, the FDA approved Xpovio (selinexor), for use in combination with the proteasome inhibitor Velcade (bortezomib) and the steroid dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous therapy. Xpovio was previously approved for several types of lymphoma.
February 2021 Vol 7 No 1

In December 2020, the FDA approved Xpovio (selinexor; from Karyopharm Therapeutics), an XPO1 inhibitor, for use in combination with the proteasome inhibitor Velcade (bortezomib) and the steroid dexamethasone, for the treatment of adults with multiple myeloma who have received at least 1 previous therapy.

Xpovio was previously approved, in combination with dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma who have received 4 or more previous therapies, and for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after 2 or more lines of systemic therapy.

The FDA approved this new indication based on the results of a randomized clinical trial of patients with relapsed or refractory multiple myeloma who had received between 1 and 3 previous therapies. Patients were divided to receive Xpovio plus Velcade and low-dose dexamethasone or standard therapy with only Velcade and low-dose dexamethasone.

The average time without disease progression was 13.9 months in patients who received Xpovio plus Velcade and low-dose dexamethasone compared with 9.5 months in patients who received only Velcade and low-dose dexamethasone, demonstrating the benefit of adding Xpovio to the treatment regimen.

The most common side effects with the 3-drug combination were nausea, fatigue, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, decreased weight, cataract, and vomiting.

Share this:

Recommended For You
Breast CancerFDA Approvals, News & Updates
Drug Watch: Recently FDA-Approved Breast Cancer Treatments
There are more treatment options available for breast cancer than ever before – and more are coming. Here’s an overview of the most recently approved medicines.
FDA Approvals, News & UpdatesLymphoma
FDA Approved Breyanzi, Novel Gene Therapy, for Large B-Cell Lymphoma
“Today’s approval represents another milestone in the rapidly progressing field of gene therapy,” said Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics Evaluation and Research.
FDA Approvals, News & UpdatesFollicular LymphomaLymphoma
FDA Approved Ukoniq, New Targeted Therapy, for Marginal-Zone and Follicular Lymphoma
Ukoniq is the first dual inhibitor of PI3K-delta and CK1-epsilon to be approved by the FDA, and is the first targeted, once-daily oral therapy option for marginal-zone or follicular lymphoma.
FDA Approvals, News & UpdatesFollicular Lymphoma
Yescarta First Gene Therapy Approved for Follicular Lymphoma
Yescarta is the first CAR T-cell therapy approved by the FDA for patients with follicular lymphoma. It uses the patient’s own genetically modified T-cells to fight the cancer.
Last modified: March 3, 2021

Subscribe to CONQUER: the patient voice magazine

Receive timely cancer news & updates, patient stories, and more.

Country