EU grants Type II variation approval for Tecvayli in multiple myeloma.- Janssen Pharma
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has granted the approval of a Type II variation application for Tecvayli (teclistamab) in multiple myeloma, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.
The EC approval was supported by positive results from the Phase I/II MajesTEC-1 study, evaluating the safety and efficacy of teclistamab in patients with RRMM.
The latest data from the study were recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2023 European Hematology Association (EHA) Congress. Patients in the study had received a median of five prior lines of therapy and, following an initial step-up phase, were initially treated with the recommended Phase II dose (RP2D) of 1.5 mg/kg teclistamab weekly (QW) administered subcutaneously. Patients who had achieved a confirmed partial response (PR) or better after four or more cycles of treatment (Phase I), or a confirmed CR or better for six months or longer (Phase II) were eligible to reduce dosing frequency to 1.5 mg/kg subcutaneously every two weeks (Q2W) until disease progression or unacceptable toxicity.
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