Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Xpovio plus Dexamethasone Combination Receives Accelerated Approval for the Treatment of Patients with Relapsed or Refractory MM

TON - August 2019, Vol 12, No 4 - FDA Updates

On July 3, 2019, the FDA granted accelerated approval to selinexor (Xpovio; Karyopharm Therapeutics), a nuclear export inhibitor, in combination with dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma (MM) who had received ≥4 previous therapies and whose disease is resistant to several other forms of treatment, including ≥2 proteasome inhibitors, ≥2 immunomodulatory agents, and an anti-CD38 monoclonal antibody.

This approval was based on results from the phase 2b STROM clinical trial of 122 patients with relapsed or refractory MM who had previously received ≥3 treatment regimens, including an alkylating agent, glucocorticoids, bortezomib (Velcade; Takeda), carfilzomib (Kyprolis; Amgen), lenalidomide (Revlimid; Celgene), pomalidomide (Pomalyst; Celgene), and an anti-CD38 monoclonal antibody; and whose MM was documented to be refractory to glucocorticoids, a proteasome inhibitor, an immunomodulatory agent, an anti-CD38 monoclonal antibody, and to the last line of therapy. Patients were treated with selinexor plus dexamethasone on days 1 and 3 of every week. Treatment continued until disease progression, death, or unacceptable toxicity.

In a prespecified subgroup analysis of 83 patients, treatment with the selinexor plus dexamethasone regimen resulted in an overall response rate of 25.3%, which included 1 stringent complete response, no complete responses, 4 very good partial responses, and 16 partial responses. The median time to first response was 4 weeks and the median duration of response was 3.8 months.

The most common adverse reactions (≥20%) were thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infections.

Related Items
FDA Grants Priority Review to New Drug Application for the RET Kinase Inhibitor Selpercatinib
Web Exclusives published on February 4, 2020 in FDA Updates, In the News, Lung Cancer, Thyroid Cancer
Tazverik Receives FDA Approval as First Treatment Specifically for Metastatic or Locally Advanced Epithelioid Sarcoma
Web Exclusives published on January 28, 2020 in FDA Updates, In the News, Sarcoma
FDA Grants Approval to Avapritinib for Patients with GIST
Web Exclusives published on January 13, 2020 in FDA Updates, Gastrointestinal Cancers, In the News, Rare Cancers
Recap of FDA Drug Approvals in 2019
Web Exclusives published on January 7, 2020 in FDA Updates, In the News
December 19, 2019 - FDA News & Updates
Web Exclusives published on December 17, 2019 in Drug Updates, FDA Updates
Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma
Web Exclusives published on December 11, 2019 in FDA Updates, In the News, Sarcoma
FDA News
TON - December 2019, Vol 12, No 6 published on December 5, 2019 in FDA Updates
FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
Web Exclusives published on December 3, 2019 in Bladder Cancer, FDA Updates, Immunotherapy
Inrebic Receives FDA Approval for Adults with Myelofibrosis
Web Exclusives published on December 2, 2019 in FDA Updates
FDA Approved Erleada for Metastatic Castration-Sensitive Prostate Cancer
Web Exclusives published on December 2, 2019 in FDA Updates
Last modified: September 9, 2019