Johnson & Johnson (J&J) has announced the US Food and Drug Administration (FDA) approval for the combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma (r/r MM).
Multiple myeloma is an incurable cancer arising from abnormal plasma cells multiplying within bone marrow.
This approval applies to patients who have undergone at least one prior treatment, including a proteasome inhibitor and an immunomodulatory agent. It aims to provide a new standard of care (SOC) and address disease relapse, which affects approximately 40% of patients.
[Image showing mechanism of action of teclistamab bispecific antibody and daratumumab CD38-directed antibody against myeloma cells]Phase III MajesTEC-3 Study Data
This FDA approval was supported by data from the ongoing Phase III MajesTEC-3 study, which compared teclistamab and daratumumab against the investigator’s choice of daratumumab/dexamethasone with either pomalidomide or bortezomib in patients with r/r MM after at least one prior therapy.
The combination showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS), reducing the risk of disease progression or death by 83% compared to standard regimens after a median three-year follow-up.
Key secondary endpoints also favoured the teclistamab-daratumumab arm, demonstrating:
- Higher overall response rate.
- Higher complete response rate.
- Minimal residual disease negativity.
- Improved OS (At three years, OS rates were 83.3% versus 65%).
Safety Profile and Adverse Events
Adverse event rates were similar between treatments, mostly involving cytopenias and infections. Cytokine release syndrome occurred in 60.1% of cases (all Grade 1/2). Serious adverse events were seen in 70.7% of patients on the new regimen, with low discontinuation rates due to adverse events.
The FDA selected the MajesTEC-3 sBLA for the Commissioner’s National Priority Voucher Pilot Programme and granted breakthrough therapy designation and real-time oncology review.
Further Oncology Milestones for J&J
In related oncology news last month, J&J received FDA approval for a new monthly dosing schedule for the combination therapy Rybrevant Faspro to treat patients with advanced, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
