Carvykti

Carvykti can be given to patients only by trained doctors in specialist hospitals.

Carvykti is prepared using the patient’s own white blood cells which are extracted from the blood, genetically modified in the laboratory and then given back to the patient as a single infusion (drip) into a vein. Carvykti must only be given to the patient whose cells were used to make the medicine.

Before having Carvykti, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.

A medicine called tocilizumab (or a suitable alternative when tocilizumab is unavailable due to a shortage), and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see description under risks section below).

Patients should be closely monitored for side effects daily for 14 days after the Carvykti infusion and then periodically for an additional two weeks. Patients are advised to stay close to a specialist hospital for at least four weeks after the Carvykti infusion.

For more information about using Carvykti, see the package leaflet or contact your doctor or pharmacist.

Carvykti contains ciltacabtagene autoleucel which consist of the patient’s own T cells (a type of white blood cell) that have been modified genetically in the laboratory, so that they make a protein called chimeric antigen receptor (CAR). CAR can attach to a protein called B cell maturation antigen (BCMA) that is present on the surface of multiple myeloma cells.

When Carvykti is given to the patient, the modified T cells attach to BCMA and then kill the myeloma cells, thereby helping to clear the multiple myeloma from the body.

A main study showed that a single infusion (drip) of Carvykti was effective at clearing cancer cells in patients with multiple myeloma that had returned and did not respond to three or more previous treatments. After one and a half year, about 84% of patients (95 out of 113) had a good response to the treatment and in 69% (78 out of 113) the signs of cancer had disappeared (complete response). Carvykti was not compared to another medicine in this study.

These results were better than those seen in other studies of patients receiving standard treatments for multiple myeloma.

The most common side effects with Carvykti (which may affect more than 1 in 5 people) are neutropenia (low levels of neutrophils), lymphopenia and leucopenia (low levels of lymphocytes or other white blood cells), anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets), hypotension (low blood pressure), pain of the muscles and bones, high level of liver enzymes, upper respiratory tract infection (nose and throat infection), diarrhoea, hypokalaemia (low level of potassium), hypocalcaemia (low levels of calcium), hypophosphataemia (low levels of phosphate in the blood), nausea, headache, cough, tachycardia (rapid heartbeat), encephalopathy (a brain disorder), oedema (fluid retention), decreased appetite, chills, fever, tiredness, as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure).

The most common serious side effects (which may affect more than 1 in 100 people) are cytokine release syndrome, thrombocytopenia, febrile neutropenia (low blood levels of neutrophils with fever), pneumonia (infections of the lungs), sepsis (blood poisoning) and a neurological disorder called ICANS (immune effector cell-associated neurotoxicity syndrome) which may include problems with speech and writing, confusion and depressed level of consciousness.

People who cannot have chemotherapy to clear away their existing white blood cells must not receive Carvykti.

For the full list of side effects and restrictions of Carvykti, see the package leaflet.

Despite the availability of an increasing number of treatments for multiple myeloma, the disease eventually usually comes back and becomes incurable. In a main study, a single infusion of Carvykti led to clinically meaningful responses rates in multiple myeloma patients whose cancer had come back and did not respond to previous treatments.

Serious side effects, particularly cytokine release syndrome and ICANS, can occur and the product information contains advice for managing them. The European Medicines Agency decided that Carvykti’s benefits are greater than its risks and that it can be authorised for use in the EU.

Carvykti has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Carvykti has been given conditional authorisation, to confirm its benefits and risks, the company that markets Carvykti will provide final follow up data from the main study and data from an ongoing study comparing Carvykti with standard chemoimmunotherapy treatment in patients whose multiple myeloma has come back and has not responded to previous treatment. The company must also carry out studies to collect more information on the long-term safety of Carvykti.

The company that markets Carvykti must ensure that hospitals where Carvykti is given have appropriate expertise, facilities and training. Tocilizumab, or suitable alternatives in case of its unavailability due to shortage, must be available for the management of cytokine release syndrome.

The company must also provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome and neurotoxicity.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Carvykti have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Carvykti are continuously monitored. Side effects reported with Carvykti are carefully evaluated and any necessary action taken to protect patients.

Carvykti received a conditional marketing authorisation valid throughout the EU on 25 May 2022.