FDA approves Talvey for the treatment of heavily pretreated multiple myeloma

Betsy Goodfellow | August 11, 2023 | News story | Medical Communications FDA, J&J, Janssen, Oncology, Talvey, multiple myeloma 

The Janssen Pharmaceutical companies of Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has granted accelerated approval of Talvey (talquetamab-tgvs) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four previous therapies.

The drug was approved under accelerated approval based on its response rate and the durability of response, however continued approval for this indication depends on verification and description of its clinical benefit in further confirmatory trials.

The drug is a bispecific T-cell engaging antibody which binds to the CD3 receptor on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells, among other cells. It is approved as a weekly or biweekly subcutaneous injection, once patients have already been treated with four previous therapies including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.

Ajai Chari, MD, director of the multiple myeloma programme and professor of clinical medicine at the University of California, US, commented: “The clinically meaningful efficacy and safety profile observed with talquetamab in heavily pretreated patients in this clinical trial, which included patients treated with prior BCMA-targeted bispecific or CAR T-cell therapy, has been notable. Patients at this stage of disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.”

Michael Andreini, president and chief executive officer of Multiple Myeloma Research Foundation, added: “Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options. Today’s approval of talquetamab provides patients with a new treatment approach for relapsed or refractory disease that is a welcome addition to the myeloma community.”

Betsy Goodfellow

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