The U.S. Food and Drug Administration approved Johnson & J&J’s combination therapy of TECVAYLI® (teclistamab‑cqyv) and DARZALEX FASPRO® (daratumumab‑hyaluronidase‑fihj) for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, expanding the company’s oncology portfolio and positioning it to compete more aggressively against bispecific antibodies and CAR‑T products in this rapidly evolving market.
The approval was based on the Phase 3 MajesTEC‑3 study, which reported a 3‑year overall survival rate of 83.3% for patients receiving the combination and a 3‑year progression‑free survival rate of 83%. The control arm achieved a 3‑year overall survival of 65.0% and a 3‑year progression‑free survival of 30%. The study also showed an 83% reduction in the risk of disease progression or death for the combination versus standard regimens, underscoring the durable clinical benefit of the new regimen.
TECVAYLI® targets BCMA and CD3, while DARZALEX FASPRO® targets CD38, creating a synergistic dual‑mechanism approach that can be administered subcutaneously. The combination is expected to be used as early as second line, offering a steroid‑sparing, well‑characterized safety profile that may improve tolerability for patients who have experienced multiple relapses.
This regulatory milestone expands J&J’s oncology portfolio, adds a high‑potential product that can capture a significant share of the growing multiple‑myeloma market, and may replace declining revenue from older therapies. The approval also positions J&J to compete more aggressively against other bispecific antibody and CAR‑T therapies in the same indication.
TECVAYLI® received accelerated approval in October 2022 as monotherapy for heavily pretreated patients, and DARZALEX FASPRO® was approved in May 2020 as a subcutaneous CD38 antibody. The combination’s approval follows a Commissioner's National Priority Voucher granted in December 2025, which expedited the review process. "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, 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," he added. "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, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson. "The FDA approval of TECVAYLI plus DARZALEX adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease," he added. "The newly approved TECVAYLI plus DARZALEX treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme.
The approval is a significant milestone for J&J’s oncology strategy, reinforcing its commitment to innovative therapies that address unmet needs in multiple myeloma and positioning the company to capture a larger share of the market as newer bispecific and CAR‑T options emerge.
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