For a patient whose myeloma has outlasted four earlier lines of treatment, the options are thin. On August 9, 2023, the US Food and Drug Administration gave accelerated approval to talquetamab-tgvs, sold as Talvey by Janssen Biotech, for adults in exactly that position: relapsed or refractory disease after a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Europe followed within two weeks. Pharmaceutical Technology reported on August 22, 2023 that the European Commission had approved Talvey for adults with refractory or relapsed multiple myeloma. In the EU the wording is a little wider. The Committee for Medicinal Products for Human Use had adopted a positive opinion on July 20, recommending conditional marketing authorisation for patients with at least three prior therapies and progression on the last one.
How it works
Talquetamab is a bispecific antibody. One arm grabs GPRC5D on myeloma cells, the other grabs CD3 on the surface of T-cells. Pulling the two together lets the T-cells attack the tumor. It was granted Priority Medicines (PRIME) designation by the European Medicines Agency in January 2021.
Patients get it by subcutaneous injection, weekly or every two weeks, after step-up doses.
What the data say
The approvals rest on MonumenTAL-1. In the group of 187 heavily pretreated patients behind the US decision, 73% responded, and 85% of those responders held the response for nine months or longer. Among patients who had already had a bispecific antibody or CAR-T therapy, 72% responded and 59% kept responding for nine months or more. Ninety-four percent of that group had received BCMA-directed treatment.
The European filing cited a very good partial response or better in 60.8% of patients at the 0.8mg/kg dose over a 12.7-month period. The 0.4mg/kg dose gave 59.5% at 18.8 months of follow-up. After prior CAR-T therapy the figure was 54.9% over 14.8 months.
Side effects are not minor. Cytokine release syndrome, taste and skin problems, nail disorders, musculoskeletal pain, fatigue, weight loss, dry mouth and diarrhoea were among the common ones.
Solène Clavreul, Head of Medical Education at Myeloma Patients Europe, said: “These approvals are good news as the response rates are promising and will provide myeloma patients with more treatment options.” GlobalData forecast $1.8bn in global sales for Talvey in 2029.
Sources
- FDA Grants Talquetamab (TALVEY) Accelerated Approval for Relapsed or Refractory Myeloma (Myeloma Patients Europe)
- Janssen's Talvey adds European approval on top of its US authorisation (Pharmaceutical Technology)
