Johnson & Johnson, a global leader in multiple myeloma therapies, has announced that the US FDA has approved a groundbreaking combo therapy for patients with relapsed multiple myeloma.
Tecvayli (teclistamab-cqyv) in combination with Darzalex Faspro (daratumumab and hyaluronidase-fihj) works by priming and activating the immune system to target myeloma cells expressing the BCMA protein, offering a potential new standard of care as early as the second line.
“This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile,” said Dr Luciano J Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, and Primary Investigator of MajesTEC-3.
“The option to use this regimen as early as second line 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. In addition, the steroid-sparing approach may reduce toxicity and improve tolerability.”
“There is a critical need to expand community-based treatment options for multiple myeloma patients, allowing them to receive care closer to home while respecting their individual treatment preferences,” said Heather Ortner Cooper, President & CEO of the International Myeloma Foundation. “This approval enhances the therapeutic landscape, giving oncologists diverse options to personalize treatment plans for each patient.”
“As the leader in hematology, we have a proud history of transforming the treatment landscape for multiple myeloma. 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,” said Imran Khan, Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson.
“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.”
The FDA decision is based on the ongoing Phase 3 MajesTEC-3 study, which compared TECVAYLI plus DARZALEX FASPRO against investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in RRMM patients.
The combination showed statistically significant improvements in progression-free survival (PFS) and overall survival (OS) after a median three-year follow-up. Patients receiving the combo had an 83% reduction in risk of disease progression or death compared to standard treatment, with a three-year PFS rate of 83% versus 30% in the control arm.
