Hetronifly
Authorised
This medicine is authorised for use in the European Union
serplulimab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Hetronifly is a cancer medicine used in adults to treat small cell lung cancer (SCLC) that has grown extensively in the lung or spread to other parts of the body (extensive-stage SCLC) and has not been treated previously. It is given together with carboplatin and etoposide (chemotherapy medicines).
SCLC is rare, and Hetronifly was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 09 December 2022. Further information on the orphan designation can be found on the EMA website.
Hetronifly contains the active substance serplulimab.
The medicine can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the treatment of cancer.
Hetronifly is given once every three weeks by infusion (drip) into a vein. The first infusion typically lasts around an hour, but if it is well tolerated, the duration of the following infusions may be reduced to around 30 minutes. If the patient develops side effects related to the infusion, the duration of the infusion may also be increased. Treatment can continue for as long as the patient benefits from it but may be paused or stopped permanently if the patient develops severe side effects.
For more information about using Hetronifly, see the package leaflet or contact your doctor or pharmacist.
The active substance in Hetronifly, serplulimab, is a monoclonal antibody, a protein that has been designed to block a receptor (target) called PD-1, which is found on certain cells of the immune system (the body’s natural defences). Some cancers can make proteins (PD-L1 and PD-L2) that combine with PD-1 to switch off the activity of the immune cells, preventing them from attacking the cancer. By blocking PD-1, serplulimab stops the cancer switching off these immune cells, thereby increasing the immune system’s ability to kill the cancer cells.
Hetronifly was shown to be effective in improving survival in a main study involving 585 adults with extensive-stage SCLC who had not been previously treated. In the study, patients were given either Hetronifly or placebo (a dummy treatment), each used alongside chemotherapy medicines (carboplatin and etoposide). Patients given Hetronifly with chemotherapy lived on average for 15.4 months while those given placebo with chemotherapy lived on average for 10.9 months.
For the full list of side effects and restrictions with Hetronifly, see the package leaflet.
The most common side effects with Hetronifly given with chemotherapy (which may affect more than 1 in 10 people) include neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low levels of white blood cells), anaemia (low levels of red blood cells), thrombocytopenia (low levels of blood platelets, components that help the blood to clot), alopecia (hair loss), nausea (feeling sick), hyperlipidaemia (high blood levels of fat), reduced appetite, hypoproteinaemia (low blood protein levels) and hyponatraemia (low blood sodium levels).
Some side effects can be serious. The most frequently reported with Hetronifly given with chemotherapy include thrombocytopenia, neutropenia, leucopenia, pneumonia (infection of the lungs) and hyperglycaemia (high blood glucose levels) or diabetes.
Hetronifly can cause side effects related to the activity of the immune system, which may cause inflammation of body organs and tissues. While these can be serious, most of the immune-related side effects resolve with appropriate treatment or on stopping Hetronifly. The most common immune-related side effects (which may affect more than 1 in 10 people) include hypothyroidism (an underactive thyroid gland) and hyperthyroidism (an overactive thyroid gland). Other immune-related side effects (which may affect up to 1 in 10 people) include skin problems, such as rash, increased liver enzymes in the blood indicating problems with the liver, anaemia, hyperglycaemia or diabetes, lung problems, colitis (inflammation of the large bowel), reduced blood levels of platelets and feeling generally unwell.
At the time of approval of Hetronifly, there was a need for additional treatments that prolong survival in extensive-stage SCLC which has a poor long-term prognosis. Despite some uncertainties regarding how representative the patients in the main study were of patients who will be treated with Hetronifly in the European Union, the medicine was shown to be effective in prolonging survival when given with chemotherapy to adults with extensive-stage SCLC who had not been previously treated. Hetronifly’s safety profile is similar to that of other cancer medicines from the same class. While some of the side effects related to the activity of the immune system can be severe, these are considered manageable.
The European Medicines Agency therefore decided that Hetronifly’s benefits are greater than its risks and that it can be authorised for use in the EU.
The company that markets Hetronifly will provide educational materials, including a patient card, about side effects affecting the immune system and severe side effects related to the infusion. The educational materials will contain information on signs and symptoms of these side effects, the importance of monitoring patients for side effects and how they should be managed if they occur.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hetronifly have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Hetronifly are continuously monitored. Suspected side effects reported with Hetronifly are carefully evaluated and any necessary action taken to protect patients.
Hetronifly received a marketing authorisation valid throughout the EU on 04 February 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
- Hetronifly
- Active substance
- Serplulimab
- International non-proprietary name (INN) or common name
- serplulimab
- Therapeutic area (MeSH)
- Small Cell Lung Carcinoma
- Anatomical therapeutic chemical (ATC) code
- L01FF12
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Hetronifly in combination with carboplatin and etoposide is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
News on Hetronifly
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