Johnson & Johnson’s multiple myeloma therapy receives FDA approval for reduced dosing

2024-02-22

上市批准临床结果加速审批免疫疗法

Johnson & Johnson’s multiple myeloma therapy receives FDA approval for reduced dosing

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来源: PMLiVE

Johnson & Johnson (J&J) has announced that a reduced dosing frequency of Tecvayli (teclistamab-cqyv) has been approved by the US Food and Drug Administration (FDA) for certain patients with relapsed or refractory multiple myeloma (RRMM).

The regulator’s decision means that RRMM patients who have achieved a complete response or better for at least six months can receive a 1.5mg/kg dose of the BCMA-targeting bispecific antibody every two weeks.

More than 35,000 new cases of multiple myeloma, a currently incurable blood cancer that affects a type of white blood cell called plasma cells, are expected to be diagnosed in the US this year.

Tecvayli, which is administered subcutaneously, was granted accelerated approval by the FDA in October 2022 to treat adults with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody.

The FDA’s latest approval on the drug was supported by positive results from the phase 1/2 MajesTEC-1 study, in which patients were initially treated with the recommended dose of 1.5mg/kg Tecvayli weekly.

Those who achieved a confirmed complete response or better for six months or longer were eligible to receive the reduced dosing frequency of 1.5mg/kg every two weeks until disease progression or unacceptable toxicity.

Rachel Kobos, vice president, oncology research and development, J&J Innovative Medicine, said: “Tecvayli is the only BCMA-targeted immune-based therapy with weight-based dosing.

“[The] approval of bi-weekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules.”

The reduced dosing frequency of Tecvayli was approved by the European Commission in August for the same patient population.

The approval comes just one month after the FDA granted full approval to J&J's bladder cancer drug, Balversa (erdafitinib).

The oral FGFR kinase inhibitor, which originally received accelerated approval by the FDA in 2019, is now fully authorised for use in adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

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