Earlier this month, Talvey received an accelerated approval as a weekly or biweekly subcutaneous therapy by the US Food and Drug Administration (FDA) as fifth-line therapy for refractory or relapsed multiple myeloma in adults. Image Credit: JHVEPhoto / Shutterstock.

Janssen’s Talvey (talquetamab-tgvs) has been approved by the European Commission as a fourth-line treatment for refractory or relapsed multiple myeloma in adult patients.

Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D). It was awarded the Priority Medicines (PRIME) designation by the European Medicines Agency (EMA) in January 2021.

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Earlier this month, it received an accelerated approval as a weekly or biweekly subcutaneous therapy by the US Food and Drug Administration (FDA) as fifth-line therapy for refractory or relapsed multiple myeloma in adults.

Similar to its FDA approval, the European approval is based on Phase I/II data from the MonumenTAL-1 study (Phase I – NCT03399799; Phase II – NCT04634552), reporting a very good partial response (VGPR) or better response in 60.8% of the patients over a 12.7-month period with 0.8mg/kg of Talvey.

The response statistics were worse with a 0.4mg/kg dose at 18.8 months of follow-up, with 59.5% of patients achieving a VGPR or better. For patients who had received CAR-T cell therapy as a prior multiple myeloma treatment, a VGRP or better response was seen in 54.9% of the patients over a 14.8-month follow-up period.

The commonly observed adverse events include cytokine release, dysgeusia, hypogammaglobulinemia, nail disorders, and weight loss.

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The European Commission also recently approved a reduced dosing frequency of 1.5mg/kg every two weeks (Type II variation) in multiple myeloma for Janssen’s other bispecific antibody, Tecvayli (teclistamab). Patients who have shown a complete response or better with Tecvayli for at least six months are eligible to receive the reduced dosing frequency.

Janssen’s bispecific antibodies are expected to be market leaders, with GlobalData forecasting $1.8bn in global sales for Talvey in 2029.

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