A multicenter review of infusion-related reactions to daratumumab for relapsed multiple myeloma in the real world setting.

BACKGROUND: Daratumumab is used in the treatment of relapsed multiple myeloma. Daratumumab infusion-related reactions can occur with the highest incidence on the first infusion. METHODS: A retrospective review of all daratumumab infusions used as part of the DVd and DRd regimens for relapsed multiple myeloma was undertaken. The review of infusion-related reactions was conducted by reviewing the treatment room nursing note on the days that daratumumab was administered. If the patient experienced an infusion-related reaction, then the data captured included if the full dose was administered. RESULTS: Daratumumab infusion-related reactions occurred most frequently on the first dose. The rates of infusion-related reactions using a split dose approach for daratumumab administration were lower than that reported in clinical trials. All of the infusion-related reactions were managed with appropriate interventions in the outpatient setting. The adoption of rapid infusion daratumumab beginning with cycle 2 of DVd and DRd was well tolerated. CONCLUSIONS: Our experience of daratumumab infusions using a split dose approach was associated with an infusion-related reaction rate in 28% of patients on cycle 1, day 1 of DVd and DRd regimens. All patients were able to complete full doses of daratumumab by utilizing split dose. The rates of daratumumab infusion-related reactions are highest on the first infusion. In addition, our adoption of rapid infusion daratumumab was safe.

Off-label infusion of biosimilar bevacizumab: A provincial experience.

The product monograph for reference bevacizumab (Avastin) and biosimilar bevacizumab (Mvasi) recommend to infuse the first dose of bevacizumab over 90 min, second dose over 60 min and third and subsequent doses over 30 min. Despite the product monograph recommendations, many institutions adopted an accelerated bevacizumab (Avastin) 0.5 mg/kg/min infusion time. Our province adopted the accelerated infusion time at time of biosimilar bevacizumab (Mvasi) adoption. Our experience with the accelerated infusion time was well tolerated in the first five months of biosimilar bevacizumab adoption across different tumor types.

Development of a Multi-Criteria Decision Analysis Rating Tool to Prioritize Real-World Evidence Questions for the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration.

The Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration developed an MCDA rating tool to assess and prioritize potential post-market real-world evidence (RWE) questions/uncertainties emerging from public drug funding decisions in Canada. In collaboration with a group of multidisciplinary stakeholders from across Canada, the rating tool was developed following a three-step process: (1) selection of criteria to assess the importance and feasibility of an RWE question; (2) development of rating scales, application of weights and calculating aggregate scores; and (3) validation testing. An initial MCDA rating tool was developed, composed of seven criteria, divided into two groups. Group A criteria assess the importance of an RWE question by examining the (1) drug's perceived clinical benefit, (2) magnitude of uncertainty identified, and (3) relevance of the uncertainty to decision-makers. Group B criteria assess the feasibility of conducting an RWE analysis including the (1) feasibility of identifying a comparator, (2) ability to identify cases, (3) availability of comprehensive data, and (4) availability of necessary expertise and methodology. Future directions include partnering with the Canadian Agency for Drugs and Technology in Health's Provincial Advisory Group for further tool refinement and to gain insight into incorporating the tool into drug funding deliberations.