US EditionMyeloma Combination Cuts Line for FDA Approval After Strong ASH Results
The FDA granted a priority voucher and fast-tracked review for teclistamab plus daratumumab after the MajesTEC-3 trial showed an 83% risk reduction in progression or death.
- On Monday, the U.S. Food and Drug Administration proactively awarded a national priority voucher to Johnson & Johnson for a Tecvayli–Darzalex regimen.
- MajesTEC-3 data presented recently at ASH showed an 83% reduction in risk of progression or death and a 3-year progression-free survival of 83.4% versus 29.7%, with plateauing curves.
- In a 587-patient trial, more than 90% of relapsed/refractory multiple myeloma patients who were progression-free at six months maintained that status over follow-up.
- The award makes the regimen the 16th recipient of a voucher and it already holds FDA breakthrough designation, with FDA Commissioner Marty Makary, MD, MPH, framing it as part of a mission to deliver more cures.
- Amid criticism of the pilot since June, two members of Congress recently launched an investigation over concerns the Commissioner's National Priority Voucher pilot program could enable corruption or undermine public confidence.
11 Articles
11 Articles
“No Plans” To Place Black Box Warning On COVID-19 Jabs, FDA Commissioner Says
FDA Commissioner Marty Makary said the agency has no plans of placing a black box warning on the COVID-19 jabs. “When it comes to the black box warning, we have no plans to put that on the COVID vaccine,” Makary said. “The safety and epidemiology center within the FDA did recommend that. It was a recommendation formally put out. But some of our scientists and leadership, like Dr. Vinay Prasad, have said they may be different today than it was in…
MedPage Today
Anti-Aging, Acupuncture and Health NewsMyeloma Combination Cuts Line for FDA Approval After Strong ASH Results
(MedPage Today) -- Under a program designed to accelerate the approval of products that could address key national priorities, the FDA said it proactively awarded a national priority voucher to teclistamab (Tecvayli) in combination with daratumumab...
Coverage Details
Bias Distribution
- 83% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
