Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM).

The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs.

Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, is a bispecific antibody that binds to CD3 on the surface of T cells and GPRC5D – a novel target on multiple myeloma cells.

The FDA’s decision was supported by positive results from the mid-stage MonumenTAL-1 study, which showed an overall response rate of more than 70% when Talvey was used as a fourth-line or later treatment.

The trial included a broad range of patients, including those previously treated with a bispecific antibody or CAR-T cell therapy.

Ajai Chari, director of the multiple myeloma programme, professor of clinical medicine at the University of California, said: “The clinically meaningful efficacy and safety profile observed with [Talvey] 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. [Talvey] as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.”

In line with the FDA’s accelerated approval pathway, under which the regulator may approve drugs earlier for serious conditions where there is an unmet medical need, Janssen will need to confirm the safety and efficacy of Talvey in a confirmatory trial.