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.
This 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: higher overall response rate, complete response rate, minimal residual disease negativity, and improved OS. At three years, OS rates were 83.3% versus 65%.
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.
Multiple myeloma is an incurable cancer arising from abnormal plasma cells multiplying within bone marrow.
J&J US haematology medical affairs vice-president Imran Khan said: “This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings.
“The FDA approval of Tecvayli plus Darzalex Faspro adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease.”
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).