J&J received approval for the Q2W dosing schedule based on data from the Phase I/II MajesTEC-1 clinical trial. Credit: Golden Shrimp / Shutterstock.com.
The newly approved regimen permits dosing with 1.5mg/kg TECVAYLI every two weeks (Q2W schedule) for patients who have had or maintained a complete response for a minimum of six months.
TECVAYLI is a subcutaneous bispecific antibody that acts on both B-cell maturation antigen (BCMA) on multiple myeloma cells and clusters of differentiation 3 (CD3) on T-cells. This approach triggers an immune response.
The therapy was initially approved in October 2022 for r/r MM patients who had undergone a minimum of four previous lines of therapy.
The latest approval for the Q2W dosing schedule is based on data from the Phase I/II MajesTEC-1 clinical trial.
The open-label, single-arm, multicohort, multicentre dose-escalation trial involved adult r/r MM patients who had previously received three or more lines of therapy.
It initially treated patients with a weekly dose of 1.5mg/kg of TECVAYLI. Those who achieved a confirmed complete response or better for six months or more could reduce their dosing frequency to 1.5mg/kg Q2W.
J&J innovative medicine oncology research and development vice-president Rachel Kobos stated: “TECVAYLI is the only BCMA-targeted immune-based therapy with weight-based dosing. The approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules.
“As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, TECVAYLI is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.”
The latest development comes after the company signed a definitive agreement to acquire Ambrx Biopharma in a $2bn cash deal.
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.