Shots:
- The US FDA has approved Tecvayli (teclistamab-cqyv) + Darzalex Faspro (daratumumab & hyaluronidase-fihj) for the treatment of adults with r/r MM, who have received ≥1L of prior therapy, incl. a proteasome inhibitor & an immunomodulatory agent
- Approval was based on the ongoing P-III (MajesTEC-3) study evaluating Tecvayli + Darzalex vs investigator’s choice of Darzalex & dexamethasone with either pomalidomide or bortezomib in the above-mentioned pts
- The trial showed PFS rate of 83% vs 30% & OS rate of 83.3% vs 65%, with higher ORR (89% vs 75.3%), CR (81.8% vs 32.1%) & MRD-negativity (58.4% vs. 17.1%) at 3yrs. follow-up; OS benefit was seen across all subgroups
Ref: J&J | Image: J&J | Press Release
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