Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the combination of TECVAYLI® (teclistamab-cqyv) and DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a treatment for relapsed/refractory multiple myeloma (RRMM). The FDA has granted Breakthrough Therapy Designation for the combination regimen, expediting its development and review. The sBLA is being reviewed through the Real-Time Oncology Review (RTOR) program. Additionally, an application has been submitted to Brazil's health agency, ANVISA.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Johnson & Johnson published the original content used to generate this news brief via PR Newswire (Ref. ID: NY39536) on December 09, 2025, and is solely responsible for the information contained therein.