U.S. FDA Approves TECVAYLI® in Combination with DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma
MWN-AI** Summary
The U.S. Food and Drug Administration (FDA) has granted approval for TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for treating adults with relapsed or refractory multiple myeloma (RRMM) who have undergone at least one prior therapy. This announcement was made by Halozyme Therapeutics, Inc. (NASDAQ: HALO) in San Diego on March 6, 2026. The approval follows promising results from the Phase 3 MajesTEC-3 study, which showcased significant improvements in progression-free survival (PFS) and overall survival (OS) in patients using the TECVAYLI and DARZALEX FASPRO combination compared to standard treatment options.
The study demonstrated an 83% reduction in the risk of disease progression or death, with a PFS rate of 83% over a median follow-up period of three years. These compelling results establish TECVAYLI plus DARZALEX FASPRO as a potential new standard of care in treating patients suffering from RRMM. Dr. Helen Torley, CEO of Halozyme, highlighted that the subcutaneous administration of both drugs offers patients a new, effective option that enhances treatment convenience.
Halozyme’s ENHANZE technology, used in DARZALEX FASPRO, allows for the subcutaneous delivery of therapies, reducing the burden on patients and improving overall treatment experiences. The company has been a pioneer in drug delivery solutions, establishing a robust portfolio of therapies aimed at streamlining treatment procedures for patients. With this FDA approval, Halozyme solidifies its position as a crucial player in the biotech landscape, focusing on improving patient outcomes and experiences.
MWN-AI** Analysis
The recent FDA approval of TECVAYLI® in combination with DARZALEX FASPRO® represents a significant advancement in the treatment landscape for relapsed/refractory multiple myeloma (RRMM). With data from the Phase 3 MajesTEC-3 study indicating an 83% reduction in the risk of disease progression or death compared to existing regimens, this combination treatment could substantially alter treatment protocols and improve patient outcomes.
For investors considering positions in companies like Halozyme Therapeutics (NASDAQ: HALO) and optimally positioned biopharmaceutical firms, this development comes at a crucial time. Halozyme's association with the innovative ENHANZE® technology, which facilitates subcutaneous drug delivery, can enhance patient experience and expand the treatment landscape. The approval may lead to increased sales for both TECVAYLI® and DARZALEX FASPRO®, potentially driving revenue growth in upcoming quarters.
From a market perspective, there are compelling reasons to explore investments in Halozyme. The company's broad partnerships across the biopharmaceutical sector and its continued innovation in drug delivery could yield significant returns. Moreover, as more treatment regimens adhere strictly to evidence-based outcomes—like those presented in the MajesTEC-3 study—products that demonstrate superior efficacy and safety profiles are likely to gain market traction.
However, potential investors should remain vigilant about the risks inherent in biotech investments, including regulatory hurdles, competitive pressures, and market acceptance challenges for new treatments. Therefore, a diversified approach, considering both established players and emerging biopharma companies, might provide a balanced risk-reward profile.
In conclusion, current market conditions and promising clinical outcomes suggest that investing in companies like Halozyme, particularly post-FDA approval of TECVAYLI®, could be strategically beneficial. Long-term focus on innovation and patient outcomes will be essential in navigating the evolving healthcare landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
FDA approval based on Phase 3 data demonstrating statistically significant improvements in progression?free survival and overall survival versus standard of care regimens
SAN DIEGO, March 6, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy.1
"The newly approved TECVAYLI plus DARZALEX FASPRO 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 based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI® in combination with DARZALEX FASPRO® demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P<0.0001).2 The three-year PFS rate was 83%,2 underscoring a durable benefit.
For more information on this approval, please view Johnson & Johnson's press release issued on March 5, 2026.
References
1. TECVAYLI® U.S. Prescribing Information
2. Maria-Victoria Mateos, et. al., Phase 3 Randomized Study of Teclistamab Plus Daratumumab Versus Investigator's Choice of Daratumumab and Dexamethasone With Either Pomalidomide or Bortezomib (DPd/DVd) in Patients With Relapsed Refractory Multiple Myeloma (RRMM): Results of MajesTEC-3, 2025 American Society of Hematology Annual Meeting. Accessed December 2025.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution facilitates the subcutaneous delivery of injected drugs and fluids, reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V. and Skye Bioscience.
Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology. Hypercon™ is an innovative microparticle technology expected to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at?home and healthcare?provider settings. The addition of Surf Bio's polymer?based hyperconcentration technology further broadens the range of biologics that can be delivered subcutaneously, meaningfully expanding the scope of opportunities across therapeutic modalities. Together, Hypercon™ and Surf Bio's technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly and argenx.
Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.
For more information, visit www.halozyme.com and connect with us on LinkedIn.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions and broadening the treatment options for the indication referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com
Sydney Charlton
Teneo
917-972-8407
sydney.charlton@teneo.com
SOURCE Halozyme Therapeutics, Inc.
FAQ**
How might the FDA approval of TECVAYLI® in combination with DARZALEX FASPRO® impact the financial performance and market share of Halozyme Therapeutics Inc. (NASDAQ: HALO) in the multiple myeloma treatment landscape?
What are the anticipated production and distribution costs for TECVAYLI® and DARZALEX FASPRO® based on this recent FDA approval from Halozyme Therapeutics Inc. (HALO), and how could this influence pricing strategies?
Considering the significant improvement in progression-free survival (83%) demonstrated in the Phase 3 MajesTEC-3 study, how will this FDA approval affect the competitive positioning of Halozyme Therapeutics Inc. (HALO) against other treatments for relapsed/refractory multiple myeloma?
What are the potential market risks and regulatory challenges that Halozyme Therapeutics Inc. (HALO) may face following this FDA approval of TECVAYLI® combined with DARZALEX FASPRO® for relapsed/refractory multiple myeloma?
**MWN-AI FAQ is based on asking OpenAI questions about Halozyme Therapeutics Inc. (NASDAQ: HALO).
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