Zynyz
Authorised
This medicine is authorised for use in the European Union
retifanlimab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Zynyz is a medicine used in adults to treat:
Merkel cell carcinoma (MCC; a type of skin cancer) that cannot be cured by surgery or radiation therapy. It is used when the cancer is metastatic (has spread to other parts of the body) or has come back and is locally advanced (has spread nearby);
squamous cell carcinoma of the anal canal (SCAC; a type of anal cancer) that cannot be removed by surgery and is metastatic or locally recurrent (has come back in the same area as the original cancer). It is used in combination with carboplatin and paclitaxel (chemotherapy medicines).
MCC and SCAC are rare, and Zynyz was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the EMA website (MCC: 13 January 2023, SCAC: 19 October 2020).
Zynyz contains the active substance retifanlimab.
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.
Zynyz is given once every 4 weeks by infusion (drip) into a vein, which lasts around 30 minutes. For MCC, treatment should continue for a maximum of 2 years or until the cancer gets worse.
When used for SCAC, Zynyz is given together with carboplatin and paclitaxel for the first 6 treatment cycles. After this, Zynyz is then given by itself every 4 weeks. Treatment should continue for a maximum of 1 year or until the cancer gets worse.
The doctor may interrupt treatment if certain side effects occur or stop it altogether if the side effects are severe.
For more information about using Zynyz, see the package leaflet or contact your doctor or pharmacist.
The active substance in Zynyz, retifanlimab, is a monoclonal antibody, a protein that has been designed to block a receptor (target) called PD-1 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 PD1, retifanlimab stops the cancer switching off these immune cells, thereby increasing the immune system’s ability to kill the cancer cells.
Merkel cell carcinoma
Zynyz was shown to be effective at clearing the cancer in an ongoing study involving 101 patients with metastatic or locally advanced MCC that came back and could not be cured by surgery or radiation. The study did not compare Zynyz with other medicines or placebo (a dummy treatment).
In the study, around 54% of patients responded to treatment, including around 17% who had a complete response (no signs of cancer) and around 37% who had a partial response (decrease in the extent of cancer). Within the study the patients’ response to treatment lasted on average for 25 months before the disease worsened.
Squamous cell carcinoma of the anal canal
A main study showed that Zynyz, given with chemotherapy, was more effective than placebo, given with chemotherapy, at increasing the amount of time people with SCAC lived without their cancer getting worse. The study involved 308 people with metastatic or locally advanced SCAC that could not be removed by surgery. All participants were given 6 cycles of the chemotherapy medicines carboplatin and paclitaxel. They also received treatment with either Zynyz or placebo every 4 weeks.
Those given Zynyz lived on average for 9.3 months without their cancer getting worse, compared with 7.4 months for those given placebo.
Other supportive data also showed that those given Zynyz lived for an average of 32.8 months compared with 22.2 months for those given placebo; however, these results were not statistically significant, meaning they could be due to chance.
For the full list of side effects and restrictions with Zynyz, see the package leaflet.
The most common side effects with Zynyz (which may affect more than 1 in 10 people) when it is used on its own include tiredness, rash, diarrhoea, anaemia (low levels of red blood cells), itching, joint pain, constipation, nausea (feeling sick), fever and reduced appetite.
The most common side effects with Zynyz (which may affect more than 1 in 10 people) when it is used together with carboplatin and paclitaxel include neutropenia (low levels of neutrophils, a type of white blood cell), itching, rash, lymphopenia (low levels of lymphocytes, a type of white blood cell), hypothyroidism (an underactive thyroid gland) and increased levels of the liver enzyme ALT which can be a sign of liver problems.
Most of the serious side effects are related to the medicine’s effect on the immune system, such as inflammation in various body organs and tissues, and rash.
At the time of approval, there were limited treatment options for patients with metastatic or advanced MCC who cannot have treatment to cure their cancer. In particular, there were no approved therapies for locally advanced MCC that came back. Despite some uncertainties associated with the design of the main study, such as the lack of a comparator medicine, Zynyz was shown to be effective in the treatment of metastatic or locally advanced MCC that has come back and cannot be cured by surgery or radiation therapy.
Zynyz also addresses an unmet medical need in adults with metastatic or locally advanced SCAC that cannot be removed by surgery, for which there were previously no medicines specifically authorised in the EU. Although there is uncertainty about the extent to which Zynyz given with chemotherapy prolongs life in these patients, EMA concluded that when these findings were considered alongside data on how long patients lived without their cancer worsening, it indicates that the medicine has a beneficial effect.
The side effects seen with Zynyz are mainly related to its effects on the immune system. Overall, the medicine’s safety profile, which is comparable to that of other cancer medicines from the same class, is considered acceptable.
The European Medicines Agency therefore decided that Zynyz’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Zynyz will provide a patient card about side effects affecting the immune system and when and where to seek help if these occur. This card will also inform healthcare professionals that the patient is being treated with Zynyz.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynyz have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Zynyz are continuously monitored. Suspected side effects reported with Zynyz are carefully evaluated and any necessary action taken to protect patients.
Zynyz received a marketing authorisation valid throughout the EU on 19 April 2024.
Product information
Latest procedure affecting product information:VR/0000247788
05/03/2026
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
- Zynyz
- Active substance
- retifanlimab
- International non-proprietary name (INN) or common name
- retifanlimab
- Therapeutic area (MeSH)
- Carcinoma, Merkel Cell
- Anatomical therapeutic chemical (ATC) code
- L01FF10
Pharmacotherapeutic group
Antineoplastic agentsTherapeutic indication
Squamous cell carcinoma of the anal canal (SCAC)
Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
Merkel cell carcinoma (MCC)
Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.
News on Zynyz
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