Lynozyfic
Authorised
This medicine is authorised for use in the European Union
linvoseltamab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Lynozyfic is a medicine used to treat adults with multiple myeloma (a cancer of the bone marrow) when the cancer has come back (relapsed) and has not responded to treatment (refractory).
It is used on its own in adults who have received at least three previous therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and whose disease got worse on the last therapy.
Lynozyfic contains the active substance linvoseltamab.
Lynozyfic can only be obtained with a prescription, and treatment should be started and supervised by a doctor experienced in the treatment of multiple myeloma.
Lynozyfic should be given in a facility with immediate access to emergency equipment and appropriate medical support to manage side effects such as cytokine release syndrome (CRS; a potentially life-threatening condition with symptoms including fever, chills, vomiting, shortness of breath, fast heartbeat, headache and low blood pressure), infusion-related reactions (IRR), and immune effector cell-associated neurotoxicity syndrome (ICANS; a neurological disorder with symptoms including problems with speech and writing, confusion and altered consciousness).
Based on the way it works, Lynozyfic should not be used in pregnant women and during breast-feeding; it should also not be used in people who have an active infection.
Lynozyfic is given as an infusion (drip) into a vein. Treatment is given once a week for the first 13 weeks, with the dose being progressively increased for the first 3 weeks. It is then given every other week. Starting from week 24, Lynozyfic may be given every four weeks, depending on the response to treatment. Treatment can continue as long as the patient benefits from it and the side effects are not too severe.
To reduce the risk of developing CRS and infusion-related reactions, patients are given medicines before treatment until they have taken two full doses of Lynozyfic without these side effects occurring. Healthcare professionals must monitor patients for signs and symptoms of CRS, IRR and ICANS during and after receiving the infusion.
The doctor may delay doses if certain side effects occur or stop treatment altogether in case of certain severe side effects.
For more information about using Lynozyfic, see the package leaflet or contact your doctor or pharmacist.
The active substance in Lynozyfic, linvoseltamab, is a monoclonal antibody (a type of protein) which is described as ‘bispecific’ because it recognises and attaches to two targets simultaneously: the B cell maturation antigen (BCMA) which is present on the surface of multiple myeloma cancer cells, and CD3, a protein present on the surface of T cells (cells in the immune system). By attaching to these targets, linvoseltamab brings the cancer cells and T cells together. This activates the T cells, which then kill the multiple myeloma cancer cells.
Lynozyfic was investigated in a main study involving 117 patients with relapsed or refractory multiple myeloma who had received at least three previous therapies for their cancer. Lynozyfic was not compared with any other treatment.
The study showed that around 71% of patients (83 out of 117) had a response to treatment varying from partial (a reduction in the signs of cancer) to complete (no signs of cancer after treatment); about 50% (58 out of 117) had a complete response. The response was maintained for an average of 29 months.
For the full list of side effects and restrictions with Lynozyfic, see the package leaflet.
The most common side effects with Lynozyfic (which may affect more than to 1 in 10 people) include musculoskeletal pain (pain in the muscles and bones), CRS, neutropenia (low levels of neutrophils, a type of white blood cell), cough, diarrhoea, anaemia (low levels of red blood cells), tiredness, pneumonia (lung infection), and upper respiratory tract infection (nose and throat infection). ICANS may affect up to 1 in 10 people.
Some side effects can be serious. The most frequent (which may affect more than 1 in 10 people) include CRS and pneumonia. COVID-19 and acute kidney injury may affect up to 1 in 10 people.
Lynozyfic has been shown to trigger complete remissions in a large proportion of patients with multiple myeloma who had previously received several therapies and whose disease had got worse on their last therapy. Long-term data are still awaited, but the response to Lynozyfic observed seems durable. Although the number of people involved in the main study was small and the medicine was not compared with other treatments, the observed benefits are considered relevant for these patients who have already received several therapies and are running out of effective options. In terms of safety, Lynozyfic can cause serious side effects, such as CRS, ICANS and infections; however, these can be managed with appropriate premedication and standard therapies. The safety profile of Lynozyfic is similar to that of other medicines of the same class.
Lynozyfic has been given conditional authorisation. This means that it has been authorised on the basis of less comprehensive data than are normally required because it fulfils an unmet medical need. The Agency considers that the benefit of having the medicine available earlier outweighs any risks associated with using it while awaiting further evidence.
The company must provide further data on Lynozyfic. It must submit final data on the duration of response and long-term safety of Lynozyfic from the main study. It must also submit the results from a new study comparing Lynozyfic with a combination of the medicines elotuzumab, pomalidomide and dexamethasone, in participants with relapsed and refractory multiple myeloma who already received one to four therapies, including a proteasome inhibitor and lenalidomide. Every year, the Agency will review any new information that becomes available.
The company that markets Lynozyfic will provide an alert card to patients receiving the medicine with important information on the risk of CRS and ICANS. The card will include instructions on when to seek urgent attention from a healthcare provider or seek emergency help.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lynozyfic have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lynozyfic are continuously monitored. Suspected side effects reported with Lynozyfic are carefully evaluated and any necessary action taken to protect patients.
Lynozyfic received a conditional marketing authorisation valid throughout the EU on 23 April 2025.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Lynozyfic
- Active substance
- linvoseltamab
- International non-proprietary name (INN) or common name
- linvoseltamab
- Therapeutic area (MeSH)
- Multiple Myeloma
- Anatomical therapeutic chemical (ATC) code
- L01FX
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
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