Concentrate for solution for infusion as monotherapy for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy

About the medicinal product

ZYNYZ contains the active substance retifanlimab.

ZYNYZ is a medicinal product used for the treatment of adults with Merkel cell carcinoma (MCC: a type of skin cancer) that is not amenable to surgery or radiation therapy. It is used when the cancer is metastatic (has spread to other parts of the body) or has recurred and is locally advanced (has spread nearby).

Since Merkel cell carcinoma is a rare and life-threatening disease, the medicinal product ZYNYZ has been authorised as an orphan drug. The term "orphan drug" is used to refer to medicines for rare diseases.

In deciding whether to authorise the medicinal product ZYNYZ, Swissmedic took into account the assessments of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), and the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of these foreign authorities, the preconditions for a full SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Summary report on authorisation are not met. Swissmedic refers to the authorisation of the foreign reference authorities: www.ema.europa.eu Procedure No. EMEA/H/C/006194/0000), www.fda.gov (Application No. 761334Orig1s000).

Further information on the medicinal product

Information for healthcare professionals: 

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}