Follow up survey for implementation of fixed-dosing of monoclonal antibodies

Kimberley M Heinhuis1, Jos H Beijnen2,3, Jeroen J M A Hendrikx2,4

  • 1Department of Clinical Pharmacology, The Netherlands Cancer Institute, Plesmanlaan 121, PO Box 90203, 1066 CX, Amsterdam, The Netherlands. k.heinhuis@nki.nl.

Background Similar to the earlier anti-cancer therapies, monoclonal antibodies were introduced in bodysize-based schedules, despite the fact that body size only modestly effects the distribution, elimination and efficacy of monoclonal antibodies. Fixed-dosing of nivolumab and pembrolizumab has recently been approved by the European Medicines Agency. Objective To investigate the implementation of fixed-dosing of nivolumab, pembrolizumab and other monoclonal antibodies in the treatment of cancer. Method An online questionnaire was distributed among Dutch hospitals in January 2019. Results The majority of the hospitals (> 60%) responded, with a good representation of the characteristics of the hospitals in the Netherlands. Most hospitals which prescribe nivolumab and/or pembrolizumab have introduced fixed-dose-based schedules. However, the dosing of the other monoclonal antibodies was still based on body size. Conclusion Fixed-dosebased schedules of nivolumab and pembrolizumab have been rapidly implemented in most Dutch hospitals after approval of the European Medicines Agency. Despite emerging evidence which supports fixed-dose-based schedules for almost all the other monoclonal antibodies, its implementation stays behind. To increase the acceptance of fixed-dose-based schedules of monoclonal antibodies in the guidelines, additional studies may be needed, which focus on evaluating exposure, activity and cost effectiveness with the attempt to uncover the exact savings in costs for patient care.

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