Janssen – a pharmaceutical arm of Johnson & Johnson – has announced that Tecvayli (teclistamab-cqyv) has been approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).
Specifically, patients treated with Tecvayli must have received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
The FDA’s decision is supported by evidence from the pivotal phase 2 MajesTEC-1 clinical trial in RRMM patients who had received a median of five prior lines of therapy.
An overall response rate of 61.8% was achieved in the study, notably with 28.2% of patients achieving a complete response or better, the company reported.
The median time to first response was 1.2 months and, with a median follow-up of 7.4 months, the estimated duration of response rate was 90.6% at six months and 66.5% at nine months.
“We are greatly encouraged by the FDA’s approval of [Tecvayli] and Janssen’s commitment to the multiple myeloma community,” said Michael Andreini, president and chief executive of the Multiple Myeloma Research Foundation.
“Multiple myeloma is a life-threatening disease with considerable unmet need, and teclistamab is an important new treatment option for patients who have faced multiple relapses,” he added.
In terms of safety, Tecvayli includes a boxed warning for cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome in addition to warnings and precautions for hepatotoxicity, infections, neutropenia, hypersensitivity and other administrative reactions and embryo-fetal toxicity.
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.
“As a clinician and researcher, I see first-hand the human toll of this incurable disease. The approval of [Tecvayli] as the first bispecific antibody in relapsed or refractory multiple myeloma is a meaningful step in helping many of these hard-to-treat patients,” said Ajai Chari, professor of medicine, division of haematology and medical oncology at the Icahn School of Medicine at Mount Sinai and study investigator.