EU expands teclistamab use to earlier-line multiple myeloma
The European Commission has expanded Johnson & Johnson's authorization for TECVAYLI (teclistamab) alone to adults whose multiple myeloma has returned or resisted treatment. Johnson & Johnson said Phase 3 evidence showed teclistamab cut the risk of disease progression or death by 71% and the risk of death by 40% versus standard care. The revised label covers patients after at least one previous therapy and permits once-monthly dosing from month 7, with eligible patients able to switch as early as month 3.
Why it matters
The decision gives Johnson & Johnson access to an earlier treatment setting in Europe and broadens the eligible patient population for TECVAYLI monotherapy. It also changes the treatment schedule for eligible patients, reducing administration frequency later in therapy.
Key facts
- 1The EC's label extension applies to patients who have received at least one earlier therapy, compared with the previous later-line monotherapy indication. onclive.com
- 2MajesTEC-9 randomized 593 patients, with 296 receiving teclistamab and 297 receiving investigator-selected PVd or Kd. onclive.com
- 3The revised dosing instructions allow some patients to move to once-every-four-weeks treatment from month 3, while the general transition occurs from month 7. rttnews.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.