TECVAYLI - Use in The Treatment of Multiple Myeloma With Central Nervous System Involvement

SUMMARY

• Johnson & Johnson does not recommend the use of TECVAYLI in a manner inconsistent with the approved labeling.
• MajesTEC-1 is a phase 1/2, multicohort study evaluating the safety and efficacy of TECVAYLI in patients with relapsed or refractory multiple myeloma (RRMM).^1,2
  • Per protocol, patients with known active central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma (MM), were excluded from enrollment.²
• MajesTEC-3 is a phase 3, randomized, open-label study evaluating the efficacy and safety of TECVAYLI in combination with DARZALEX FASPRO (Tec-Dara subcutaneous [SC]) vs investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy (LOTs).^3,4 
  • Per protocol, patients with known active CNS involvement or clinical signs of meningeal involvement of MM, were excluded from enrollment.⁴
• MajesTEC-9 is an ongoing, phase 3, randomized, open-label, multicenter study comparing TECVAYLI with investigator’s choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who previously received 1-3 prior LOTs including an anti-CD38 monoclonal antibody (mAb) and lenalidomide.^5,6
  • Per protocol, patients with known active CNS involvement or clinical signs of meningeal involvement of MM, were excluded from enrollment.⁶
• A search of the scientific literature retrieved limited information from the following resources describing the use of bispecific antibody treatment in patients with MM and CNS involvement^7-12:
  • Retrospective studies have reported CNS responses and safety of bispecific antibodies.^7-10
  • Two case studies have reported CNS involvement in MM.^11,12

PRODUCT LABELING

• TECVAYLI (teclistamab-cqyv) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/TECVAYLI-pi.pdf.
• DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.; https://www.jnjlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX+Faspro-pi.pdf

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 12 June 2026.