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.

Thedrugwasapprovedunderaccelerated 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.”

Peter Lebowitz MD PhD, global therapeutic area head of Oncology at Janssen Research & Development, added: “The approval of Talvey, our fifth innovative therapy and second bispecific antibody approved for the treatment of multiple myeloma, demonstrates our commitment to expanding our portfolio of medicines to help address unmet needs for patients who continue to face challenges with this complex haematologic malignancy. Our team of scientists never settles in their determination to discover and develop effective therapies. With the discovery of this new antigen, we continue to strive for research breakthroughs while remaining focused on delivering curative regimens in our commitment to eliminate cancer.”