Linvoseltamab is approved for use in patients with multiple myeloma that has returned or worsened after prior treatment.
WASHINGTON, July 11, 2025 – The U.S. Food and Drug Administration (FDA) recently approved linvoseltamab-gcpt (Lynozyfic™) for use in adults with multiple myeloma that has returned or worsened despite earlier treatment.
In a clinical trial of 80 patients who had received at least four rounds of other treatments for their multiple myeloma, 70% had their disease respond to treatment with linvoseltamab and 45% had a complete response, meaning that there were no detectable signs of cancer.
“It’s great news that we have yet another treatment advance for multiple myeloma,” says Lore Gruenbaum, Ph.D., The Leukemia & Lymphoma Society’s Chief Scientific Officer. “Thanks to many advances over the last few years, people with myeloma are living longer than ever before, but we have more work to do. Our work continues until we have a cure for all patients with this disease.”
In the U.S. alone, an estimated 4,000 people have multiple myeloma that has come back after four or more rounds of therapy.
Linvoseltamab is a bispecific antibody, a newer type of immunotherapy, that works by directing a person’s T cells to kill the cancerous cells.
The median duration of response to treatment has not yet been reached in the trial, as many patients whose disease responded to linvoseltamab have not yet had their cancer come back.
Giving patients with blood cancer more time
The Leukemia & Lymphoma Society has approximately $40 million invested across multi-year research commitments to improve the lives of patients living with myeloma.
One of these multi-year research commitments was awarded to Alfred Garfall, M.D., of the Perelman School of Medicine at the University of Pennsylvania. Garfall and other esteemed physician-scientists and researchers are investigating the safety and efficacy of limited-duration bispecific antibody treatment. Patients with myeloma treated with a bispecific antibody today generally receive it on a continuous basis, without any breaks.
Long-term use, however, has been associated with side effects, including infection. The hope is that patients can be given what’s known as a treatment holiday, sparing them from long-term complications without sacrificing effectiveness.
A separate academic grant recently awarded to a group of prestigious scholars is for the investigation of whether a high-fiber plant-based diet, along with virtual coaching, can improve outcomes and quality of life for patients with newly diagnosed myeloma.
LLS’s Chief Medical Officer Gwen Nichols, M.D., recently spoke with the lead investigator of this study, Urvi A. Shah, M.D., M.S., to highlight the significance of this research.
If you or a loved one need personalized disease, treatment or support information, you can contact one of our Information Specialists: https://www.lls.org/support-resources/information-specialists