FDA Greenlights New Treatment for Advanced Blood Cancer
The drug, known as linvoseltamab but sold under the name Lynozyfic, is for adults with multiple myeloma whose cancer has returned or isn't responding well to treatment, especially if they've already tried at least four other treatments. Lynozyfic is said to offer a flexible dosing plan tailored to each patient's needs.
In multiple myeloma, plasma cells (a type of white blood cell that makes antibodies against diseases) multiply abnormally, leading to too much of a protein called immunoglobulin in bones and blood that crowds out healthy blood cells in the bone marrow. This damages the bones and eventually multiple organs as the disease worsens and spreads. B-cell maturation antigen (BCMA) is a protein found in high levels on multiple myeloma cells that promotes their survival and growth, making the cancer more aggressive and difficult to treat. Despite undergoing three to four therapies, many patients see their cancer return, highlighting the need for new treatments, especially those targeting BCMA.
Lynozyfic was approved after a study with 80 people who had multiple myeloma and had already tried at least four other treatments. About 70% of them got better with Lynozyfic. Of those people, about 9 out of 10 were still doing well after nine months, and about 7 out of 10 were still doing well after a year. Scientists watched the patients for about 13 months.
About 45% of patients receiving Lynozyfic had no measurable sign of cancer after treatment, according to a news release from Regeneron Pharmaceuticals, the drug's maker.
'The FDA approval of Lynozyfic is a welcome milestone. It provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response,' said Diane Moran, interim CEO and senior vice president of strategic planning at the International Myeloma Foundation.
Lynozyfic works by connecting special immune cells called T cells to cancer cells in the blood (multiple myeloma cells). This helps the T cells find and kill the cancer cells that usually hide from the immune system. Lynozyfic can be given quickly. It could be an option for people who can't get a similar but stronger treatment called CAR T therapy, which is harder to make and can have serious side effects.
Lynozyfic is given through a drip into your vein. At first, people get three small doses that get bigger each time: 5 milligrams, 25 milligrams, and then 200 milligrams. After that, they get 200 milligrams once a week for 10 weeks, then once every two weeks. If they're doing well at week 24 and have had at least 17 doses, they can switch to once every four weeks.
The most common side effects are bone or muscle pain, feeling tired, headache, cough, shortness of breath, weakness, diarrhea, and feeling sick to your stomach.
Some serious side effects can happen, like a very strong immune reaction, problems from the infusion, or nerve damage. Because of these risks, patients may need to stay in the hospital for 24 hours after their first two doses. Lynozyfic is only given through a special safety program to help keep people safe.
Other warnings include a higher chance of infections, low blood cell counts, liver problems, and harm to fetuses. People need to use birth control during treatment and for three months after their last dose. Patients should not drive, use heavy machines, or do dangerous activities for 48 hours after each first dose or if they have new nerve problems like confusion, shaking, or numbness until they feel better.
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