What is Imlygic - Talimogene Laherparepvec and what is it used for?
Imlygic is a cancer medicine used to treat adults with melanoma (a form of skin cancer) that cannot be removed by surgery and has spread to other parts of the body (except bones, lungs, brain and other internal organs).
Imlygic is a type of advanced therapy medicine called a 'gene therapy product'. This is a type of medicine that works by introducing genes into the cells of the body. It contains the active substance talimogene laherparepvec.
How is Imlygic - Talimogene Laherparepvec used?
Treatment with Imlygic should be initiated and administered under the supervision of a physician experienced in the treatment of cancer.
Imlygic is available as a solution for injection in two different strengths. It is given by injection into melanomas. The lowest concentration of Imlygic is used to administer the first dose, while the higher concentration is used for subsequent doses. The second dose is given three weeks after the first dose and treatment is continued every two weeks for at least six months, unless the doctor believes that the patient is not receiving any benefit from the medicine. The volume of medicine to be injected depends on the size of the tumor and the number of tumors to be treated. For more information, see the Summary of Product Characteristics (included in the EPAR).
How does Imlygic - Talimogene Laherparepvec work?
The active substance in Imlygic, talimogene laherparepvec, is a type of gene therapy called an 'oncolytic virus'. It comes from the weakened herpes simplex 1 virus (the cold sores virus). This virus has been modified to infect melanoma cells and multiply within them. Imlygic uses the internal organization of melanoma cells to multiply, overwhelm and ultimately kill tumor cells. Although Imlygic can enter healthy cells, it is not designed to multiply within them.
Furthermore, Imlygic induces the production of a protein called GM-CSF by infected melanoma cells. This protein stimulates the patient's immune system (the body's natural defenses) to recognize and destroy melanoma cells.
What benefits of Imlygic - Talimogene Laherparepvec have been shown in studies?
Imlygic was studied in one main study involving 436 patients with inoperable melanoma that had spread to other parts of the body (except bones and brain). The 24-month study compared Imlygic and GM-CSF injected to The main measure of effectiveness was the percentage of patients who responded to treatment and maintained that response for at least six months, before their health deteriorated or needed another therapy. Response to treatment was defined as at least a 50% reduction in the signs of melanoma. Taking into account the subgroup of patients in the study (249 patients) who did not have diffuse disease of the lungs or other internal organs, 25% (41 out of 163) of patients treated with Imlygic had a prolonged response to treatment compared with approximately 1% (1 in 86) of patients treated with GM-CSF.
What are the risks associated with Imlygic - Talimogene Laherparepvec?
The most common side effects with Imlygic (which may affect more than 1 in 4 people) are tiredness, chills, pyrexia (fever), nausea, flu-like illness and pain at the injection site. These side effects were largely mild or moderate in severity. The most common serious side effect (affecting around 2 in 100 people) was cellulitis (infection of the upper layers of the skin). Imlygic contains a herpes virus that can reactivate later, causing herpes infections such as cold sores. . In patients who have a weak immune system (eg, HIV-infected patients), Imlygic can cause a more widespread disease. Imlygic should not be given to patients with severely compromised immune systems as reactivation of the virus may cause a disease. "herpes infection spread to other parts of the body." For the full list of restrictions and side effects reported with Imlygic, see the package leaflet.
Why has Imlygic - Talimogene Laherparepvec been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) highlighted that Imlygic is a therapy based on an innovative mechanism of action that could be a valuable addition to existing therapies for late stage inoperable melanoma, an area with need dissatisfied doctors. Patients with inoperable melanoma spread to other parts of the body (except bones, brain and lungs) have shown a sustained reduction in melanoma after treatment with Imlygic, but it is not yet known whether this benefit will result in longer survival. Regarding safety, Imlygic was relatively well tolerated and the undesirable effects were largely mild or moderate in severity. The CHMP therefore considered that the benefits of Imlygic outweigh the identified risks and recommended that it be approved. use in the EU.
What measures are being taken to ensure the safe and effective use of Imlygic - Talimogene Laherparepvec?
A risk management plan has been developed to ensure that Imlygic is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Imlygic, including the appropriate precautions to be followed by healthcare professionals and patients.
The company has implemented a controlled distribution program to qualified centers to ensure compliance with low temperature storage and handling requirements and to control distribution to patients. As part of this program, the medicine will only be provided to physicians. who have received the appropriate educational material on the risk of herpes infection, especially in patients with compromised immune systems, the risk of transmitting the virus to healthcare professionals or others in close contact with the patient (accidental exposure) and the necessary precautions from for administration and disposal of the product. Patients will also receive educational materials and a Patient Alert Card with information on the risks associated with the medicine and how to avoid accidental exposure to Imlygic.
The company will also conduct three studies to further characterize the benefits and risks of Imlygic, including a study of Imlygic in patients with advanced melanoma that can be surgically removed.
Further information can be found in the summary of the risk management plan.
More information about Imlygic - Talimogene Laherparepvec
For more information about Imlygic therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
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