The Medicines and Healthcare products Regulatory Agency (MHRA)
has today (6 July 2026) approvedRetifanlimab(ZYNYZ) as the
first treatment given to adults with advanced Merkel cell skin
cancer that has spread or returned and cannot be cured with an
operation or radiotherapy.
Merkel cell carcinoma (MCC) is a rare and aggressive type of skin
cancer that develops from Merkel cells, specialised
neuroendocrine cells found in the top layer of the
skin.
Retifanlimabworks by helping the body's immune system
recognise and attack cancer cells. It blocks a pathway that
cancer cells can use to avoid being detected by the immune
system, allowing immune cells to better identify and
destroy them.
Retifanlimabis administered via diluted intravenous infusion
over 30 minutes.
In a study of 101 adults with advanced Merkel cell carcinoma who
had not previously received treatment for their advanced disease,
53.5% of patients responded to treatment with Retifanlimab.
Of these, 16.8% had no detectable signs of cancer after
treatment, while 36.6% experienced tumour shrinkage. Among
patients who responded to treatment, the response typically
lasted just over two years.
Beach, MHRA Executive Director of
Healthcare Quality and Access, said:
This approval provides the first treatment option for adults
with advanced Merkel cell carcinoma that has spread or
returned and cannot be cured with surgery or radiotherapy.
As with all medicines, we will continue to
closely monitor the safety and effectiveness
of retifanlimab as it is used more widely.
For the full list of all side effects reported with this
medicine, see Section 4 of the PIL or the SmPC available on the
MHRA website.
Notes to editors
-
The approval was granted on6 July 2026 to Incyte
Biosciences UK Ltd
-
This product wassubmittedand approved via International
Recognition Procedure (IRP).
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More information can be found in the Summary of Product
Characteristics and Patient Information Leaflets which will
be published on the MHRA Products website within 7 days of
approval.
