Recommendation supported by unprecedented Phase 3 data, demonstrating that TECVAYLI^® in combination with daratumumab achieved statistically significant improvements in progression-free and overall survival versus standard of care¹
Pending approval, this novel complementary immunotherapy combination is positioned to delay disease progression for patients treated as early as second line, with 83% of patients alive at three years¹

BEERSE, BELGIUM, June 26, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI^® (teclistamab) in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

Advancing complementary immunotherapies to improve patient outcomes
Teclistamab and daratumumab work in a mechanistically complementary manner by engaging multiple tumour and immune directed pathways.^1,2 When combined, daratumumab modulates the immune system to create a more favourable immune microenvironment and enhances T-cell fitness and activation, amplifying teclistamab-mediated killing of myeloma cells.^1,2 This combination improves patient outcomes by using immunotherapies earlier in the treatment journey when patients’ immune systems are more robust.^1,²

Expert and company perspectives support the earlier use of teclistamab combination in multiple myeloma care
“Unprecedented data show a meaningful extension in overall survival and minimal progression events observed after the first six months. More than 90% of patients receiving the combination who were progression-free at six months remained progression-free at three years, highlighting the potential for durable long-term disease control.” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “This CHMP opinion marks an important step towards establishing the off-the-shelf immunotherapy combination of teclistamab plus daratumumab as a new standard of care earlier in the treatment pathway for multiple myeloma.”

“At Johnson & Johnson our ambition is to leverage the full potential of our comprehensive multiple myeloma portfolio, to strengthen patient outcomes at every stage of the treatment continuum,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By advancing innovative immunotherapies such as teclistamab and combining them with a well-established standard of care like daratumumab, we are building on our deep scientific expertise to deliver more integrated, combination-based approaches that can continue to raise expectations for patient care.”

Teclistamab plus daratumumab SC achieves meaningful and sustained improvements in patient outcomes
The CHMP recommendation is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), evaluating the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients who have received 1–3 prior lines of therapy.³

At nearly three years of follow-up, results show an 83.4% reduction in the risk of disease progression or death in patients treated with teclistamab plus daratumumab SC, compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.0001).¹ More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, demonstrating sustained disease control over time.¹ Overall survival (OS) favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.¹^,2At three years, OS rates were 83.3% for the combination and 65.0% for standard of care.¹ Both progression-free survival and OS benefits were clinically meaningful and statistically significant.¹

Manageable safety profile observed with teclistamab combination
Teclistamab plus daratumumab SC demonstrated a safety profile consistent with the well-known profiles of the individual therapies.¹^,³^,⁴All cases of cytokine release syndrome were Grade 1/2, did not lead to treatment discontinuation, and were manageable and resolved.¹ Rates of Grade 3/4 treatment-emergent adverse events (TEAEs) were comparable to standard of care regimens (95.1% vs. 96.6%) with cytopenia and infection most commonly observed.¹ Grade ≥3 infections decreased over time with the use of immunoglobulin supplementation and infection prophylaxis, along with a switch to monthly dosing.² Discontinuations due to TEAEs were low and similar between study arms (4.6% vs. 5.5%).¹

About the MajesTEC-3 Study
MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed or refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.⁵The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.⁵The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.⁵

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.⁶In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.⁷

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.³^,⁸Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.^1,3 Teclistamab is currently being evaluated in several combination studies.⁵^,^9,10^,11

To date, more than 26,000 patients have been treated worldwide with teclistamab.¹²

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf.

▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.³

About Daratumumab and Daratumumab SC
Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 748,000 patients worldwide.¹³ Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.^5,¹⁴ Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.^5,¹⁵Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE^® drug delivery technology.⁵

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.⁵^,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.⁵Daratumumab may also have an effect on normal cells.⁵ Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.^{17,18,19,20,21,22,23,24,25,26}

For further information on daratumumab, please see the Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf.

About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.²⁷^,2⁸ In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.²⁹^,³⁰ In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.³¹ Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.³²^,³³^,3⁴ Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.³⁵

About Johnson & Johnson
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/innovativemedicine/emea/. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

Key Search Terms

MajesTEC-3 Phase 3 clinical trial
TECVAYLI
Teclistamab
DARZALEX
Daratumumab
Teclistamab and daratumumab combination
TECVAYLI and DARZALEX combination
Relapsed and or refractory multiple myeloma (RRMM)
Early relapse multiple myeloma
Second line multiple myeloma treatment
First relapse therapy for multiple myeloma
Treatment resistance in multiple myeloma
Progression-free survival (PFS) in multiple myeloma
Overall survival (OS) in multiple myeloma
Multiple myeloma
Bispecific antibody therapy
CD38-targeted therapy
BCMA-targeted bispecific therapy
Combination immunotherapy
EMEA haematology pipeline
Multiple myeloma innovation
Multiple myeloma treatment

END

References:
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CP-583164
June 2026

CONTACT: Media contact: 
Jenni Mildon 
jmildon@its.jnj.com   
+44 7920 418 552 

Investor contact: 
Jess Margevich 
investor-relations@its.jnj.com

CHMP recommendation advances Johnson & Johnson’s TECVAYLI®▼ (teclistamab) plus daratumumab as a potential standard of care for relapsed/refractory multiple myeloma