Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that teclistamab has been granted a conditional marketing authorisation (CMA) by the European Commission (EC) as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM).
With this approval, teclistamab becomes the first bispecific antibody to be approved for the treatment of patients with RRMM worldwide.
Specifically, patients being treated with teclistamab must have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy, the company said.
William Hait, executive vice president, chief external innovation, medical safety and global public health officer, Johnson & Johnson, said: “This first approval for teclistamab worldwide marks significant progress for patients with relapsed and refractory multiple myeloma.
“Teclistamab is an important addition to our multiple myeloma portfolio. We are continuing to invest in clinical development to expand its potential and offer novel options for patients and physicians.”
The approval is supported by evidence from the MajesTEC-1 trial – an open-label, phase 1/2 study assessing the safety and efficacy of teclistamab in adults with RRMM.
In the study, 104 out of 165 patients achieved an overall response rate of 63% after a median of five prior lines of therapy. Moreover, 58.8% of patients receiving teclistamab achieved a very good partial response or better and 39.4% achieved a complete response or better, the company reported.
Multiple myeloma is an incurable blood cancer affecting plasma cells – a type of white blood cell – found in bone marrow. If plasma cells become damaged, they can transform and grow in an abnormal way. The production of abnormal cells can result in an overcrowding in the bone marrow, suppressing the growth of healthy cells.
As the disease progresses, relapses for patients become more aggressive with each new line of therapy and remissions become progressively shorter.