Johnson & Johnson’s standout trial results for its Tecvayli and Darzalex Faspro pairing in previously treated relapsed or refractory multiple myeloma have earned the company the third ultra-speedy approval awarded under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program.
On top of the combo nod, which specifically covers patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, the FDA also threw in a bonus label update for Tecvayli by converting the accelerated approval it won in 2022 to a traditional approval.
The agency considered J&J’s phase 3 MajesTEC-3 study solid enough confirmatory evidence to support Tecvayli’s full approval as a monotherapy as well, it explained in a release.
“Multiple myeloma is notoriously challenging to treat,” FDA Commissioner Marty Makary, M.D., said in the release. “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.”
J&J unveiled what it described as “unprecedented” MajesTEC-3 study results in December at the 2025 American Society of Hematology annual meeting. Soon after, FDA leaders got in touch with J&J about doling out the CNPV.
“When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Makary said at the time.
In the study, the pairing of Tecvayli and subcutaneous Darzalex delivered an 83% reduction in the risk of disease progression or death compared to standard regimens, including Darzalex and dexamethasone with either Bristol Myers Squibb’s Pomalyst or Takeda’s Velcade, at nearly three years of follow-up. More than 90% of patients who were progression-free at six months remained that way at three years, while overall survival rates came out to 83.3% for Tecvayli-Darzalex compared to 65% in the control arm.
With the results, J&J quickly submitted a supplemental drug application to the FDA under the agency’s Real-Time Oncology Review program, a framework that allows the agency to evaluate the data before the full application is formally submitted, it said at the time.
As for the CNPV pathway, the initiative launched last June and aims to cut drug review timelines from six months or longer down to one or two months for medicines that align with U.S. national priorities. In J&J’s case, the company had formally filed its approval bid 55 days prior to its March 5 nod, according to the FDA.
This is the same review pathway the FDA used for last week’s CNPV nod, which went to Boehringer Ingelheim’s lung cancer treatment Hernexeos. Before the quick succession of oncology CNPV approvals, the first nod under the new program went to USAntibiotics in December.
“The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people,” Makary said in the latest approval announcement.
Not all companies have been successful with the new regulatory pathway. Last month, Disc Medicine received an FDA rejection for its rare blood disease candidate, leading to commercial team layoffs this week.
J&J, for its part, sees the approval as “another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings,” the company’s vice president of U.S. hematology medical affairs, Imran Khan, M.D., Ph.D., said in a release.
“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,” Khan added.
While multiple myeloma bispecific Tecvayli and star CD38 antibody Darzalex could put pressure on CAR T-cell therapies including J&J’s own Carvykti, the company sees the combo as a way to offer an equally efficacious therapy to community doctors who can’t refer patients to the CAR-T treatments, Khan told Fierce Pharma in a December interview.