Lynozyfic (linvoseltamab-gcpt) is a prescription injection medicine for people with a type of blood cancer called multiple myeloma, whose cancer has come back (relapsed) or worsened (refractory) after trying at least four different types of treatment. Previous treatments must include specific medicines that boost the immune system or help kill the cancer cells. The FDA approved Lynozyfic in 2025 for adults with this condition.
Lynozyfic is given as an infusion into a vein (IV) by a health care provider in a hospital once every week for your first few months of treatment. After that, it is given every two or four weeks.
How Does Lynozyfic Work in Multiple Myeloma?
Multiple myeloma is a type of blood cancer that happens in the bone marrow (the soft, spongy tissue inside the bones). Lynozyfic attaches to a protein called BCMA that is found on the surface of the cancer cells. This may help the immune system recognize, attack, and kill the cancer cells.
How Will I Receive Lynozyfic?
Lynozyfic is given as an IV infusion. Your Lynozyfic infusion will always be given at a hospital where a health care provider can monitor you for any side effects that might happen. Your first few doses of Lynozyfic will be given once weekly over several hours. You may be given other medicines like Tylenol, Benadryl, or steroids by mouth or IV before the start of the infusion to lower your risk of certain side effects. The first dose of Lynozyfic will be smaller, and it will be slowly increased each week over the first few weeks. This is called “step-up” dosing. Step-up dosing is used to try to lower your chance of a severe side effect called cytokine release syndrome. For your first two doses, you will stay at the hospital for at least a day after your infusion to monitor for side effects.
After the first few weeks of treatment, you will continue to get a dose of Lynozyfic once weekly for about two more months. If you do not experience cytokine release syndrome during your first few doses, the length of time of your infusion may be shorter for these doses. If you continue to tolerate treatment with Lynozyfic, your future doses may be spaced out even further (every two or four weeks), and your infusion time may be decreased even more.
How Was Lynozyfic Studied for Treating Multiple Myeloma?
One clinical study called LINKER-MM1 was done to look at the benefits and risks of Lynozyfic in people with relapsed or refractory multiple myeloma. People in the study were treated with Lynozyfic, given as an IV infusion once per week over 14 weeks, then once every other week. People who had a very good partial response with Lynozyfic were able to space out their infusion to every four weeks after six months. People continued getting Lynozyfic until their cancer got worse, they had serious side effects, they chose to stop, they passed away, or the study ended.
Who was included in the study?
To be included in the study, people had to meet the following requirements:
- Be 18 years old or older
- Have relapsed or refractory multiple myeloma that was progressing
- Have previously received at least three types of cancer treatment: a proteasome inhibitor (for example, carfilzomib (Kyprolis)), an immune system modulator (for example, lenalidomide (Revlimid)), and an anti-CD38 antibody (for example, daratumumab (Darzalex))
- A score of 0 or 1 on a system called the Eastern Cooperative Oncology Group (ECOG) scale, which measures how people can take care of themselves, do their daily activities, and move around. The ECOG score goes from 0 to 5. Higher scores show more challenges with these tasks.
Who was excluded from the study?
People could not be in the study if any of the following applied to them:
- Have a diagnosis of certain other types of cancer or blood disorders
- Have a history of certain conditions affecting the nerves and ability to move, or seizures in the past 12 months
- Had previous treatments that worked in a similar way to Lynozyfic
- Had certain recent cancer treatments
- Have signs of multiple myeloma affecting their brain and nervous system
- Have an ECOG score of 2 or higher
What was the study population?
- A total of 117 people in the study got Lynozyfic.
- The average age of these people was 70 (range of 37-91).
- About 55% of them were male and 45% were female.
- About 71% of them were White, 17% Black or African American, and 9% Asian.
- About 27% had an ECOG score of 0, and about 73% had a score of 1.
- All had an average of five previous types of cancer treatment, with a range from two to 16 previous cancer treatments.
- About 42% had stage I, about 35% had stage II, and about 18% had stage III multiple myeloma.
What benefits were the study researchers trying to see?
The focus of this study was to find out how well Lynozyfic worked to manage multiple myeloma.
To learn this, the researchers looked at the number of people whose cancer improved some (partial response) or disappeared completely (complete response) after getting Lynozyfic. This is called overall response rate (ORR).
What Were the Main Benefits of Lynozyfic Seen in the Study?
Some people did not stay in the study long enough or did not meet the rules for measuring how well Lynozyfic worked. So researchers looked at the main results from 80 people out of the 117 who enrolled in the study.
Among these 80 people:
- About 70% showed some improvement after getting Lynozyfic (ORR).
- About 45% showed a complete response.
- About 19% showed a very good partial response.
- About 6% showed a partial response.
- The time it took for cancer to improve was between about two weeks to about six months. About half of the people saw results within about one month.
- Among those who saw a response to Lynozyfic, about 90% were still seeing benefits from the treatment after nine months, and about 70% after one year.
Your results may differ from what was seen in clinical studies.
What Are the Side Effects of Lynozyfic, and How Can I Prevent or Manage Them?
Lynozyfic may cause serious or life-threatening side effects because of how it affects the immune system. These side effects happen after a sudden release of immune substances called cytokines in the body.
Cytokine release syndrome
The sudden release of cytokines in the blood is called cytokine release syndrome (CRS). The symptoms of CRS include a fever (100.4 F or higher), chills or shaking, dizziness or lightheadedness, a fast heartbeat, and trouble breathing. In the clinical trial, CRS mostly happened after the first doses. In half of the people who had CRS, it happened within about 11 hours after getting a dose, while in others, it happened during the infusion through up to seven days after the infusion. CRS was mild in about one-third of people in the study.
Neurologic problems
High levels of cytokines in the fluid around the brain and the spinal cord can cause a condition called ICANS, which affects the brain and nerves. The symptoms of ICANS include headaches, muscle jerks or spasms, feeling restless, numbness and tingling (feeling like "pins and needles"), confusion, trouble speaking, shaking (tremor), double vision, changes in your handwriting, problems walking, muscle weakness in your body or face, hearing loss, and burning, throbbing, or stabbing pain. ICANS can happen at the same time that CRS does or a few days after.
Call your health care provider right away if you notice any of the signs or symptoms of CRS or neurologic problems at any time during your treatment with Lynozyfic.
Liver problems
Lynozyfic can cause serious liver problems. Your health care provider will regularly test you for any issues while you are getting Lynozyfic. Make sure to tell them if you feel tired all the time, do not have an appetite, have stomach pain, have dark urine, or notice yellowing of your skin or the whites of your eyes.
Other common side effects of Lynozyfic are infections and low levels of white blood cells. Avoid being around people who are sick, and stay away from crowded places, especially during the cold and flu season. Wear a well-fitting mask in busy areas for added safety. Tell your health care provider if you have a fever, chills, cough, difficulty breathing or chest pain, sore throat, pain while peeing, or if you generally feel weak or unwell.
These are not all the possible side effects of Lynozyfic. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can report side effects to the FDA at 800-FDA-1088 (800-332-1088) or www.fda.gov/medwatch. You can also report side effects to the drugmaker, Janssen Biotech, at 800-526-7736.
What Types of Drug Interactions Can Happen?
Tell your pharmacist and other health care providers about all the other prescription and nonprescription medicines, vitamins, supplements, and herbal products you take before starting Lynozyfic and while you are getting it.
Lynozyfic may affect how other medicines work in your body. The cytokines that are released after you take Lynozyfic can interfere with a protein called CYP that helps break down some medicines. This can lead to higher levels of these medicines in your body, which may be harmful. Your health care provider will keep an eye on how Lynozyfic affects these medicines and adjust their doses, if needed.
How Can I Get Lynozyfic?
Lynozyfic is only available through a special program, from certain pharmacies, and to certain people. It is important that you keep all of your appointments, including labs or other testing, while taking Lynozyfic. If you have any questions about this program, you can go to lynozyficrems.com or call 855-212-6391.
If you need help paying for Lynozyfic, the drugmaker may be able to assist you. Check out their Lynozyfic Surround support program at www.lynozyfic.com/patient-support to learn more about getting help with costs, your insurance coverage, and how to get your Lynozyfic infusions. You can also contact the drugmaker at 844-746-4363.
