Drug Approval | November 21, 2025
Merck receives EU nod for first subcutaneous formulation, promising faster cancer treatment
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
This is the first and only subcutaneous immune checkpoint inhibitor available in Europe
The company will present new data from across over 20 cancer types and multiple treatment settings at European Society for Medical Oncology Congress 2025
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
The safety profile of Opdualag observed in this analysis was consistent with the known profiles of nivolumab and relatlimab
This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
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