HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
The approval allows the regimen to be used after treatment with a proteasome inhibitor and an immunomodulatory agent and is based on results from the Phase 3 MajesTEC-3 clinical study.
Johnson & Johnson said the two therapies work together to activate the immune system to target myeloma cells that express the B-cell maturation antigen (BCMA) protein.
The approval is supported by trial data showing statistically significant improvements in progression-free survival and overall survival compared with standard treatment regimens.
According to the study results, the therapy reduced the risk of disease progression or death by 83% compared with standard treatment.
Researchers reported that 83.3% of patients treated with the combination therapy were alive three years after treatment, compared with 65% of patients receiving standard therapies.
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 the MajesTEC-3 study, said the therapy could expand treatment options earlier in the disease course.
“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,” Costa said.
The trial also showed higher response rates compared with standard treatment.
Overall response rates were 89% for the TECVAYLI and DARZALEX FASPRO regimen compared with 75.3% for the control group.
Complete response rates were 81.8% compared with 32.1%, and minimal residual disease negativity was observed in 58.4% of treated patients compared with 17.1% in the control arm.
Heather Ortner Cooper, president and chief executive officer of the International Myeloma Foundation, said the approval expands treatment options for patients.
“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,” Cooper said.
Imran Khan, vice president of U.S. hematology medical affairs at Johnson & Johnson, said the approval adds another therapy to the company’s multiple myeloma treatment portfolio.
The MajesTEC-3 trial evaluated teclistamab combined with daratumumab compared with investigator-selected regimens that included daratumumab and dexamethasone with either pomalidomide or bortezomib.
Researchers said adverse events in the study were generally consistent with previous experience with the therapies.
Grade 3 or 4 treatment-emergent adverse events occurred in 95.1% of patients receiving the TECVAYLI and DARZALEX FASPRO combination and 96.6% of patients receiving standard therapy.
The FDA granted the supplemental application Breakthrough Therapy Designation and included it in the Commissioner’s National Priority Voucher Pilot Program.
Multiple myeloma is a blood cancer that affects plasma cells in bone marrow and is considered incurable.
More than 35,000 people in the United States are diagnosed with the disease each year, and more than 12,000 deaths occur annually.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.