HQ Team
June 3, 2025: Regeneron Pharmaceuticals, Inc.’s drug for a type of blood cancer in patients who have received four treatments before, and the disease has recurred, has received the US regulator’s green light.
The drug, Lynozyfic or linvoseltamab-gcpt, is meant for adults with a type of blood cancer called multiple myeloma, the second most common blood cancer, according to a company statement.
The US Food and Drug Administration granted the drug an accelerated approval in patients whose cancer has come back or not responded to treatment after trying at least four different therapies, including specific types of drugs used for this cancer.
Lynozyfic works by helping the body’s immune system attack the cancer cells. It is a kind of antibody that connects immune cells to the cancer cells, making the immune cells more effective at killing the cancer.
The medicine is the first of its kind approved by the FDA that can be given every two weeks starting from the 14th week of treatment, and then every four weeks if the patient shows a good response after about six months.
70% response
The approval was based on a clinical trial where 70% of patients responded to the treatment, and nearly half of them had no signs of cancer after treatment.
A majority of patients maintained their improvement for at least a year. The treatment can cause serious side effects, including a strong immune reaction called cytokine release syndrome and neurological problems, so patients need to be carefully monitored in hospitals during the first doses.
The drug has a boxed warning and includes precautions for infections, neutropenia, hepatotoxicity and embryo-fetal toxicity. The most common adverse reactions were musculoskeletal pain, cough, upper respiratory tract infection, diarrhoea, fatigue, pneumonia, nausea, headache and dyspnea.
The treatment offers a new option for patients who have already tried many treatments without success. It is designed to reduce the number of hospital visits over time, which can make it easier for patients to manage.
‘Patient-centric advancement’
“The FDA approval of Lynozyfic represents meaningful progress for the multiple myeloma community. Lynozyfic demonstrated early, deep and durable responses in heavily pre-treated patients,” said Sundar Jagannath, M.D., Network Director of the Center of Excellence for Multiple Myeloma at Mount Sinai in New York City and a trial investigator.
“Lynozyfic has a convenient response-adapted dosing regimen, which provides the potential to extend time between doses. This is a significant patient-centric advancement that could help reduce treatment burden,” he said.
There are more than 187,000 new cases of multiple myeloma diagnosed globally every year, with more than 36,000 diagnosed and 12,000 deaths anticipated in the US in 2025.
In the US, there are about 8,000 people who have the disease that has progressed after three lines of therapy, and 4,000 whose disease has progressed after four or more therapies.
‘Advancing programs for Lynozyfic’
“With a 70% overall response rate in heavily pre-treated patients, we believe Lynozyfic is poised to potentially become a new standard of care for multiple myeloma,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron.
“Furthermore, given the strength of the data, we are rapidly advancing our broad clinical development program for Lynozyfic – exploring its use in earlier lines of therapy as monotherapy and in novel combinations – as we aim to meaningfully advance care for patients.”
The disease is characterised by the proliferation of cancerous plasma cells that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury.
Despite treatment advances, multiple myeloma is not curable, and while current treatments can slow the progression of the cancer, most patients will ultimately experience cancer progression and require additional therapies.