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BIOLOGIC
Lynozyfic (linvoseltamab-gcpt) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults with relapsed or refractory multiple myeloma.
Lynozyfic is a type of medicine called a bispecific antibody. It attaches to T cells (part of the immune system) and to myeloma cells at the same time. This helps the immune system find and kill the cancer cells.
By targeting this pathway, the medication may help reduce abnormal cancer cell activity, manage symptoms, and slow disease activity.
Doctors prescribe Lynozyfic for adults with multiple myeloma that has come back or has not responded after at least four prior treatments. These treatments must have included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
Lynozyfic is given as an intravenous infusion, which means it is given through a vein.
Treatment starts with smaller “step-up” doses over the first three weeks. After that, it is usually given once a week for a period of time, then every two weeks. Some people who respond well may later receive it every four weeks.
The recommended starting dose of Lynozyfic for multiple myeloma in adults begins with:
This is followed by 200 milligrams once a week for 10 doses (from week 4 to week 13).
If people have a very good response at or after week 24 and have received at least 17 doses of 200 milligrams, the dosing schedule may be changed to 200 milligrams every four weeks.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Lynozyfic for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, the most common side effects occurred in about 21 percent to 53 percent of people. These include:
Lynozyfic can cause serious side effects that require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Regeneron Pharmaceuticals, the manufacturer of Lynozyfic, offers the Lynozyfic Surround Commercial Copay Program. Eligible people with commercial insurance may pay as little as $0 out of pocket for Lynozyfic.
The Lynozyfic Surround program also provides benefits investigation, prior authorization and appeals support, help with out-of-pocket costs, and educational resources to support you throughout your treatment journey. To learn more, visit the Lynozyfic Surround site or call 844-746-4363 and choose option 1.
If you are able to become pregnant, your doctor will check if you are pregnant before you start Lynozyfic. Blood tests, liver tests, and immunoglobulin levels will also be done before and during treatment to monitor blood cell counts and overall safety.
Lynozyfic is only available through a special safety program because it can cause serious side effects like cytokine release syndrome and neurologic problems. You may need to stay in the hospital for 24 hours after your first and second step-up doses.
Do not drive or operate heavy machinery for 48 hours after each step-up dose, or if you have any new neurologic symptoms, until the symptoms go away.
You will receive a Lynozyfic Patient Wallet Card. You should keep this with you at all times, and show it to all of your healthcare providers.
Your healthcare team will monitor you closely. Get medical help right away if you have symptoms such as fever, trouble breathing, confusion, or trouble staying awake.
Tell your doctor if you have any allergies to linvoseltamab-gcpt or any ingredients in Lynozyfic.
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Also let your doctor know if you have had recent infections or nervous system problems in the past.
If you miss a dose, call your healthcare provider as soon as possible. Your doctor will decide how to restart treatment based on your last dose and how much time has passed.
If you are pregnant, planning to become pregnant, or breastfeeding while taking Lynozyfic, talk with your doctor about the risks and benefits.
If you are able to become pregnant, use effective birth control during treatment and for three months after your last dose. Do not breastfeed during treatment and for three months after your last dose.
These answers are fact-checked by our editorial staff.
How effective is Lynozyfic?
In a study of 80 adults with relapsed or refractory multiple myeloma who had already received at least four prior lines of treatment, 70 percent responded to Lynozyfic. Also, 45 percent had a complete response or better.
The median time to first response was 0.95 months (ranging from 0.5 to six months). Among people who responded, an estimated 89 percent were still responding at nine months, and 72 percent were still responding at 12 months.
How long does Lynozyfic take to work for multiple myeloma?
In the clinical study of Lynozyfic in adults with relapsed or refractory multiple myeloma, the median time to first response was 0.95 months. Initial responses were seen from 0.5 months to six months.
Should I take Lynozyfic for multiple myeloma if I have an infection?
People with active infections were not included in clinical studies. Lynozyfic can cause serious, life-threatening, or fatal infections.
You should be monitored for signs of infection before and during treatment. Treatment may be delayed or stopped depending on how severe the infection is.
On MyMyelomaTeam, people share their experiences with multiple myeloma, get advice, and find support from others who understand.
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