The bispecific antibody is used to treat patients with relapsed or refractory multiple myeloma (R/R MM) who have achieved and maintained a complete response for at least 6 months; this approval allows a dosing frequency of 1.5 mg/kg every 2 weeks.
The FDA has approved a supplemental Biologics License Application for teclistamab-cqyv (Tecvayli) at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months.
Teclistamab was previously approved in October 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least 4 prior therapies.
The new biweekly dosing regimen for Tecvayli is intended for patients with RRMM who have achieved and maintained a complete response or better for a minimum of 6 months.
TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
Johnson & Johnson (JNJ) Announces FDA Approval of TECVAYLI Biweekly Dosing streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.
/PRNewswire/ Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application.
UPDATE: AstraZeneca completes USD1.1 billion acquisition of Icosavax lse.co.uk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from lse.co.uk Daily Mail and Mail on Sunday newspapers.