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Janssen’s Talvey receives positive CHMP opinion

The treatment is a monotherapy for treating adult patients with refractory or relapsed multiple myeloma.

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Talvey.

The treatment – also known as talquetamab – is a monotherapy for treating adult patients with refractory or relapsed multiple myeloma who have already received at least three prior therapies. These could have included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The individuals in question should also have demonstrated disease progression since the last therapy.

Talquetamab is a bispecific subcutaneous antibody that attaches G protein-coupled receptor class C group 5 member D (GPRC5D) – a novel target on multiple myeloma cells – and CD3, on T-cells.

Meanwhile, the CHMP also recommended the approval of a type two variation for teclistamab. This version provides a decreased, bi-weekly dosing schedule of 1.5mg/kg every other week among patients who have achieved a complete response or better for six months or over.

Edmond Chan, senior director of EMEA therapeutic area lead haematology at Janssen-Cilag Limited, was optimistic about the EMA’s verdict: “With talquetamab, a novel bispecific antibody targeting GPRC5D, we look to build on our legacy of innovation and bring forward a vital new treatment option for patients with relapsed and refractory multiple myeloma, who have a poor prognosis.”

He added: “Today’s recommendation from the CHMP marks an exciting step for patients who continue to face the challenges of this difficult-to-treat blood cancer. We look forward to working with health authorities to bring talquetamab to patients in need across the region as soon as possible, while we continue our focus on enhancing a robust multiple myeloma portfolio of therapeutics and regimens.”

In spite of recent advances, multiple myeloma is still a highly heterogenous and incurable disease that presents uniquely depending on the patient. As the disease progresses, and with each successive line of treatment, responses tend to decrease and patient outcomes become worse.

Therefore, an unmet need remains for more therapeutic options that incorporate alternative modes of action, including for patients treated with prior bispecific or CAR-T cell therapies.