J&J's Tecvayli claims third national priority FDA approval
Johnson & Johnson's Tecvayli has been approved as part of a combination regimen with its Genmab-partnered Darzalex Faspro as a second-line therapy for relapsed or refractory multiple myeloma, just 55 days after it was filed with the FDA.
The rapid approval – the third under the FDA's recently-introduced Commissioner's National Priority Voucher (CNPV) programme – moves BCMAxCD3 bispecific T-cell engager Tecvayli (teclistamab) up the treatment pathway from its previous use as a fifth-line or later therapy for the blood cancer. It will now be an option for patients previously treated with a regimen including a proteasome inhibitor and an immunomodulatory agent.
According to J&J, Tecvayli plus Darzalex Faspro now offers a "new standard of care" for the 40% of patients with multiple myeloma who experience disease relapse after initial treatment.
The green light comes on the back of the MajesTEC-3 study reported at last year's ASH congress, which showed significant improvements with the regimen in both progression-free survival (PFS) and overall survival (OS) compared to anti-CD38 antibody Darzalex Faspro (daratumumab plus hyaluronidase) and dexamethasone.
The trial - which included patients who were naive or sensitive to anti-CD38 drugs - showed an 83% reduction in PFS with Tecvayli/Darzalex Faspro, as well as a significant 54% improvement in OS.
Lead investigator Dr Luciano Costa of the University of Alabama at Birmingham in the US said that earlier use of the regimen "is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical."
He also pointed out that a steroid-sparing regimen – without dexamethasone – may reduce toxicity and improve the tolerability of treatment for patients.
Since the MajesTEC-3 data was reported, J&J has also revealed positive results from the MajesTEC-9 trial, in which second-line or later monotherapy with Tecvayli reduced PFS by 71% and OS by 40% compared to standard care in a post-Darzalex patient population.
The FDA selected the new indication for Tecvayli as one of the recipients of a CNPV, which can reduce review times to a matter of weeks and is designed to bring important new therapies to patients more quickly and plug gaps in the domestic supply of essential medicines.
Tecvayli's approval comes a few days after Boehringer Ingelheim became the second company to get a CNPV approval, for oral HER2 inhibitor Hernexeos (zongertinib), indicated for treatment-naïve, HER2-positive advanced non-small cell lung cancer (NSCLC).
The first came in December and involved a US-made version of the widely used antibiotic Augmentin XR (amoxicillin-clavulanate potassium), intended to reduce the national reliance on imported products.
"The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people," said FDA Commissioner Marty Makary.
"Multiple myeloma is notoriously challenging to treat," he added. "When we saw the most impressive second-line myeloma trial results in history, we acted quickly to bring this finding to everyday Americans wrestling with the disease."
