Janssen receives positive CHMP opinion for Talvey in multiple myeloma

2023-07-25

上市批准细胞疗法免疫疗法临床结果临床研究

Janssen receives positive CHMP opinion for Talvey in multiple myeloma

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来源: PMLiVE

Janssen, a Johnson & Johnson company, has announced that its bi-specific antibody, Talvey (talquetamab), has been recommended by the European Medicines Agency’s (EMA) human medicines committee for use in certain patients with relapsed or refractory multiple myeloma (RRMM).

The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended conditional marketing authorisation for the drug as monotherapy in adult RRMM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor proteasome inhibitor, and an anti-CD38 antibody, and who have demonstrated disease progression on their last therapy.

Multiple myeloma is a blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. In Europe, more than 50,900 people were diagnosed with the disease in 2020, and more than 32,400 patients died.

Despite recent advances, Janssen reports that there is an unmet need for more therapeutic options with different modes of action, including for patients treated with prior bi-specific or CAR-T cell therapies, to “better address the unique characteristics of every patient’s individual needs through different cellular targets”.

Talvey, which is administered by subcutaneous injection, works by binding to CD3, on T-cells, and GPRC5D, which is a novel target on multiple myeloma cells.

The CHMP’s recommendation for the therapy was supported by positive results from the phase 1/2 MonumenTAL-1 study, which evaluated its safety profile and efficacy in RRMM patients.

Edmond Chan, senior director EMEA therapeutic area lead haematology, Janssen-Cilag Limited, said the recommendation marked “an exciting step” for patients who continue to face the challenges of RRMM.

He said: “With [Talvey], a novel bi-specific antibody targeting GPRC5D, we look to build on our legacy of innovation and bring forward a vital new treatment option for patients with RRMM, who have a poor prognosis.

"We look forward to working with health authorities to bring Talvey 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 the same announcement, Janssen outlined that the CHMP had also recommended the approval of a type two variation for Tecvayli (teclistamab), which is already authorised in the EU for use in certain RRMM patients.

This version provides a reduced, bi-weekly dosing schedule of 1.5mg/kg every other week for patients who have achieved a complete response or better for six months or longer.

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