FDA approves treatment for refractory multiple myeloma
Posted: 5 July 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
The US Food and Drug Administration (FDA) has given accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients.
The therapy is intended for patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody.
Efficacy was evaluated in 83 patients with RRMM who were treated with Xpovio in combination with dexamethasone. At the end of the study, the overall response rate was measured at 25.3 percent.
Further clinical trials are required to verify and describe the treatment’s clinical benefit. Xpovio also received Orphan Drug Designation (ODD).
“While there is no cure for multiple myeloma, there are FDA-approved treatments to target the cancer and slow down the spread of the disease. Sadly, often over time, patients can exhaust all available treatments and still see their disease progress,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence. “Today we approved a treatment under our accelerated approval programme that provides a treatment option for patients with multiple myeloma with no available therapy.”