Xpovio receives FDA approval for refractory or relapsed multiple myeloma

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has approved Xpovio (selinexor) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Xpovio is sponsored by Karyopharm Therapeutics Inc.

FDA granted Xpovio accelerated approval in 2019 in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma 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 Xpovio 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 compared to the standard twice-weekly bortezomib plus low-dose dexamethasone.

The main efficacy outcome measure was progression free survival assessed by an independent review committee using International Myeloma Working Group response criteria. The estimated median PFS was 13.9 months (95% CI: 11.7, Not Estimable) for the SVd arm and 9.5 months (95% CI: 7.6, 10.8) for the Vd arm (estimated hazard ratio 0.70; 95% CI: 0.53, 0.93).

Table of Contents

YOU MAY BE INTERESTED IN

Cell and gene therapies have made incredible strides over the past decade. The 2024 FDA approvals of the first T-cell receptor therapy for the treatment of metastatic synovial sarcoma and the first tumor-infiltrating lymphocyte therapy for the treatment of unresectable or metastatic melanoma mark a significant turning point for solid tumor treatment.xxx:more
The intersection of diabetes, obesity and cancer represents an important and underappreciated challenge in medicine. Apart from smoking, overweight is now the leading modifiable risk factor for cancer. With the global epidemic of overweight and diabetes driving cancer incidence across multiple organ sites, understanding the metabolic underpinnings of this relationship has never been more critical.
The Pazdurs in their garden with their dog, Cleo. The dog’s full name is Cleopatra, Queen of Denial.In 1999, Rick Pazdur went in for a “perfunctory” final interview at FDA. Thinking it would only take a few minutes, his wife, Mary, decided to wait and have a quick cup of coffee at a nearby restaurant—Hooters.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login