Outstanding trial results for the combination of Tekvayli and Darzalex Faspro in previously treated relapsed or refractory multiple myeloma have earned Johnson & Johnson the third super-accelerated approval granted to the company under the FDA Commissioner’s National Priority Voucher (CNPV) testing program.
In addition to the combination approval, which specifically targets patients who have received at least one type of therapy, including a proteasome inhibitor and an immunomodulator, the FDA also gave Tekvayli a bonus label update that converts the accelerated approval it received in 2022 into a traditional approval.
The agency determined in a release that J&J’s Phase 3 MajesTEC-3 trial provided sufficient solid evidence to support full approval of Tekvayli as a monotherapy.
“Multiple myeloma is notoriously difficult to treat,” FDA Commissioner Marty McCurry, MD, said in the release. “When we saw the most impressive secondary myeloma trial results in history, we acted quickly to communicate this discovery to the everyday Americans fighting this disease.”
In December, J&J announced the results of its “unprecedented” MajesTEC-3 study at the 2025 American Society of Hematology Annual Meeting. Shortly thereafter, FDA leaders contacted J&J about distributing CNPV.
“When a treatment shows positive trial results, we have a duty to patients to act quickly,” McCurry said at the time.
In this study, the combination of subcutaneous Tecvayli and Darzalex reduced the risk of disease progression or death by 83% over approximately three years of follow-up compared to standard regimens containing Darzalex and dexamethasone and Bristol-Myers Squibb’s Pomalyst or Takeda Pharmaceuticals’ Velcade. More than 90% of patients who were progression-free at 6 months remained progression-free at 3 years, and overall survival was 83.3% with Tekvayli Darzalex, compared with 65% in the control group.
Following the results, J&J immediately submitted a supplemental drug application to the FDA under the FDA’s Real-Time Oncology Review Program. The program is a framework that allows FDA to evaluate data before a complete application is formally submitted, the company said at the time.
This is the same review pathway the FDA used for last week’s CNPV approval of Boehringer Ingelheim’s lung cancer drug Hernexeos. The first U.S. antibiotic to be approved under the new program was in December, ahead of a flurry of CNPV approvals in oncology.
The CNPV program was launched last June and aims to shorten drug review timelines from more than six months to one to two months for drugs that align with U.S. national priorities. In J&J’s case, the company filed a formal application for approval 55 days before the March 5 consent, according to the FDA.
“FDA is now actively working to reduce idle time to facilitate meaningful treatment for the American people,” McCurry said in announcing the latest approval.
Not all companies have been successful in making the transition to regulation. Last month, Disc Medicine received an FDA rejection of a rare blood disease candidate, leading to layoffs of its commercial team earlier this month.
For its part, J&J views this approval as “another critical milestone in improving outcomes for patients living with this disease with a unique regimen that is accessible to patients in all clinical settings,” Imran Khan, MD, Ph.D., the company’s medical vice president of U.S. hematology, said in a J&J release. “FDA approval of Tecvayli and Darzalex Faspro adds powerful new treatment options to our multiple myeloma portfolio and moves us closer to our ambition to one day cure this disease.”
Although the multiple myeloma bispecific Tecvayli and the star CD38 antibody Darzalex could put pressure on J&J’s own CAR-T cell therapies, including Carvykti, the company sees the combination as a way to provide equally effective treatment to doctors in areas where they cannot refer patients for CAR-T therapy, Khan told Fierce Pharma in a December interview.
