NEW BRUNSWICK (dpa-AFX) - Drug major Johnson & Johnson (JNJ) announced Friday that its TECVAYLI (teclistamab) monotherapy has been approved by the European Commission to treat adult patients with relapsed/refractory multiple myeloma or RRMM, expanding treatment options from first relapse.
Multiple myeloma is a complex blood cancer, which affects a type of white blood cell called plasma cells, which are found in the bone marrow.
Teclistamab is an off-the-shelf or ready-to-use bispecific antibody. It is a subcutaneous injection, which redirects T-cells through two cellular targets to activate the body's immune system to fight cancer.
Teclistamab is currently being evaluated in several combination studies. So far, more than 30,700 patients have been treated worldwide with teclistamab.
JNJ said the European approval is based on Phase 3 results demonstrating significant progression-free and overall survival benefits, with teclistamab reducing risk of disease progression or death by 71% and risk of death by 40%, compared with the standard of care.
The EC has approved an indication extension of TECVAYLI (teclistamab) to treat RRMM who have received at least one prior therapy.
The EC recently approved teclistamab plus daratumumab, and the latest indication extension introduces teclistamab monotherapy as an additional second-line treatment option for patients living with RRMM through both combination and monotherapy approaches.
The company noted that the updated label will replace the current monotherapy indication and posology, and introduce a simplified dosing schedule with monthly dosing frequency from month 7 onwards.
Eligible patients may also transition to monthly dosing as early as month 3.
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson, stated, 'With positive Phase 3 results from both MajesTEC-3 and MajesTEC-9, we continue to build evidence for teclistamab-based regimens across a broad second-line patient population. Together, these studies highlight the potential of teclistamab to become a foundational option at first relapse, while reinforcing our ambition to improve long-term outcomes for patients.'
Teclistamab received EC approval in August 2022 to treat patients with RRMM who 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.
In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM.
In pre-market activity on the NYSE, JNJ shares were trading 0.74 percent lower at $265.70, after closing Thursday's regular trading 3.81 percent higher.
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