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iStock, chuenmanuse A “significant number of patients” could see a cure for multiple myeloma within the next two decades, one expert told BioSpace . Here are five therapies that could change the treatment paradigm. The third approval under the FDA’s Commissioner’s National Priority Voucher program went to Johnson & Johnson’s multiple myeloma combo treatment Tec-Dara last week, continuing recent momentum seen in this space. It also comes on the heels of a relatively rare occurrence in the pharma industry: the comeback of a once-disgraced drug. GSK’s Blenrep— withdrawn from the market in November 2022—secured a new FDA approval last October as a combo regimen in the third-line setting for multiple myeloma. With Blenrep back on the market, GSK rejoins its fellow Big Pharms in a multiple myeloma market that also includes J&J and Takeda, Pfizer and Bristol Myers Squibb. Despite a powerhouse roster chipping away at the cancer, however, multiple myeloma remains a disease that is treated and managed, not cured, Saad Usmani, scientific advisory board member at the International Myeloma Society, told BioSpace in an email. “There is growing interest now in defining how long we treat patients,” Usmani said, adding that the field is now at a place where it can consider the possibility of a cure. “This is the next phase of our research in multiple myeloma. “I am very confident that we will be able to provide 20–25+ year disease control and potentially cure a significant number of patients in the next decade,” Usmani continued, adding that he expects to have better predictive models for prognosis and tools to monitor disease response. “We will have defined duration of therapy for patients who will be able to enjoy good quality of life.” Last month, the FDA released new guidance aimed at getting novel drugs with early efficacy signals to patients more quickly, signaling the evolving nature of the space. Here, BioSpace looks at some of the most promising emerging therapies—medicines that, if they prove their mettle in the clinic, could bring the industry closer to the future that Usmani envisions. Cancer FDA’s Multiple Myeloma Guidance Highlights Decade of Success New draft guidance from the FDA on multiple myeloma endpoints reflects the new technology available to assess disease and how patient journeys have changed with better treatments. January 30, 2026 · 4 min read · Dan Samorodnitsky Regeneron Refines Dosing, Safety with Lynozyfic Kicking off this list is Regeneron’s bispecific antibody Lynozyfic, which in July last year notched the FDA’s accelerated approval for the fifth line treatment of relapsed or refractory multiple myeloma. The approval comes after an initial rejection in August 2024, though the regulator at the time found no problems with Lynozyfic’s safety or efficacy, instead citing issues with a third-party manufacturer. Lynozyfic targets both the BCMA and CD3 proteins, in turn bridging T cells with their target: malignant B cells. Data from the Phase 1/2 LINKER-MM1 study, which formed the foundation of Lynozyfic’s regulatory package, showed a 70% objective response rate in treated patients, including a 45% complete response rate or better. With Lynozyfic, Regeneron is a late-comer to the scene, Rajesh Kumar, functional head of Forecasting at DelveInsight, told BioSpace in an email. Still, the company has nevertheless managed to set itself apart. “Regeneron leveraged its late-mover advantage to refine dosing and safety,” according to Kumar. Kumar also pointed to a standout element of the LINKER-MM1 study: allowing patients who hit a certain efficacy bar to switch to a monthly dosing schedule. This dosing profile, Kumar said, offers “a convenience edge over competitors’ biweekly schedules,” which in turn could drive physician and patient preference. Lynozyfic’s accelerated approval could mean a potential $600 million revenue opportunity for Regeneron, analysts at BMO Capital Markets estimated in a July 3 note to investors. The company continues to develop Lynozyfic for multiple myeloma, looking at its potential to enter earlier—even potentially pre-malignant—treatment settings. AbbVie, Ichnos Glenmark Go From Two Targets to Three In July 2025, AbbVie and Ichnos Glenmark Innovation linked up to take the bispecific attack on multiple myeloma one step further, adding another cancer marker to the mix. At the heart of the collaboration is ABBV-2001, a trispecific antibody that works by helping the body recognize the malignant cells and boosting the immune system’s anti-cancer response. For this technology, AbbVie paid $700 million upfront and promised up to $1.225 billion in development, regulatory and commercial milestones, plus royalties. “The dual tumor-antigen targeting strategy is designed to enhance avidity even at low antigen expression while improving safety versus first-generation bispecific antibodies,” Aparna Thakur, assistant project manager of Forecasting and Analytics at DelveInsight, told BioSpace in an email, explaining that ABBV-2001 binds to BCMA and CD38 on myeloma cells, and to CD3 on T cells. This trispecific approach is potentially the first in its class, Thakur said. “The hope is that the trispecific binding nature of this drug candidate will result in an improved clinical outcome and potentially outperform bispecific competitors.” AbbVie and Ichnos are running the Phase 1 TRIgnite-1 study in patients with relapsed or refractory disease, which is set to complete in July 2027. Early data presented last June demonstrated a 74% overall response rate (ORR), including a 30% high-complete or stringent-complete response rate. All patients in this trial had been heavily pretreated. The companies will release more data from TRIgnite-1 this year . Caribou Targets ‘Paradigm Shift’ With Off-The-Shelf CAR T Therapy For California-based Caribou Biosciences, the best answer to multiple myeloma is one that’s already been proven: CAR T therapies. Indeed, many of the biggest pharma companies have shown the efficacy of this approach, with the FDA approving products such as Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti . FDA FDA Greenlights BMS, J&J CAR-T Therapies for Earlier Multiple Myeloma Treatment The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients. April 5, 2024 · 3 min read · Heather McKenzie and Nadia Bey Read more The question for Caribou isn’t whether CAR T is effective, CEO Rachel Haurwitz told BioSpace in an email, but about access. “Access is a major constraint” for current CAR Ts, Haurwitz continued, estimating that roughly 1 in 10 patients who need the therapy actually get it. There are several reasons for this, she explained, but one big factor is that current CAR Ts are autologous—meaning they use cells that come from the patients themselves. Autologous cell therapies “are mostly administered in larger academic institutions,” Haurwitz said. “Many [multiple myeloma] patients cannot wait the weeks to months necessary to receive a dose,” she added. Autologous CAR T therapies are also more challenging to manufacture and deliver to patients due to stringent FDA requirements, according to an industry report from DelveInsight. Caribou’s solution is CB-011, an allogeneic CAR T—meaning it can be available off-the-shelf. Instead of using cells from a patient, CB-011 takes samples from healthy donors, which then undergo genome editing using the biotech’s proprietary platform, Haurwitz explained. The result is a construct that can seek out malignant myeloma cells while also minimizing the risk of immune rejection. Phase 1 data released last November support this mode of action. In the fourth-line-or-later setting, CB-011 resulted in a 92% ORR , including a 75% complete response rate. Safety was “manageable,” Caribou said at the time, with no cases of graft-versus-host disease—a common risk with allogeneic transplants. The biotech is enrolling patients in the dose expansion portion of this study and expects to share more data later this year, Haurwitz said. “An allogeneic CAR-T cell therapy . . . would potentially be paradigm shifting for MM treatment,” she told BioSpace . “It would allow patients to be treated with a single dose closer to where they live, without the need to wait for manufacturing.” C4’s Cemsidomide Picks Up MOMENTUM in 2026 2026 is shaping up to be a big year for C4 Therapeutics and its lead asset, the multiple myeloma drug cemsidomide. Designed to be taken orally, cemsidomide is a small-molecule degrader of IKZF1/3, zinc finger transcription factors that are highly expressed in multiple myeloma and, in turn, drive the expression of genes that help the cancer cells survive and grow. Two of the most common cancer drugs today—Bristol Myers Squibb’s Revlimid and Pomalyst —similarly target and destroy these two transcription factors. In September last year, C4 released Phase 1 clinical data for cemsidomide, touting a 50% ORR at a 100-ug dose level when used alongside dexamethasone. A lower, 75-ug dose resulted in a 40% ORR. This early-stage study focused on heavily pretreated patients with relapsed or refractory disease. The readout also showed that degradation of IKZF1 reached over 50% after cemsidomide treatment, while IKZF3 breakdown exceeded 80%—which C4 said at the time supported the drug’s mechanism of action. The company added that cemsidomide was “generally well tolerated” across all doses tested, though there was one case of febrile neutropenia that was classified as grade 4—a severe life-threatening adverse event that needed urgent medical attention. No deaths were reported. The Massachusetts biotech will accelerate the advancement of cemsidomide this year, with its Phase 2 MOMENTUM trial combining the drug with dexamethasone set to start this quarter . By midyear, C4 also plans to release additional Phase 1 data for cemsidomide, building up to initial MOMENTUM findings in the back half of 2027. Exicure Wants To Make Stem Cell Transplants Easier Exicure is taking a unique approach to multiple myeloma with cell mobilizer burixafor, aiming to facilitate smoother stem cell transplantations. Specifically, burixafor is an oral drug that blocks CXCR4, a receptor involved in how cells move from one part of the body to another, according to the biotech’s website . By disrupting the CXCR4 signaling cascade, burixafor allows the release of stem cells from the bone marrow into the bloodstream, eventually taking them to the peripheral circulation where they can be more readily harvested. CXCR4 has been implicated in cancer , with heightened expression linked to worse outcomes, according to Exicure. While burixafor itself doesn’t directly address multiple myeloma, it facilitates stem cell transplantation , a relatively common treatment option for patients with this malignancy. The procedure involves bombarding the patient and their bone marrow with an aggressive regimen of chemotherapy to reduce and hopefully deplete the cancer cells there. Then, stem cells, which were removed ahead of time—with the help of agents like burixafor—can be reintroduced into the body to rebuild the bone marrow. Topline Phase 2 data released in December last year showed that nearly 90% of patients treated with burixafor were able to have at least 2 × 10⁶ CD34+ cells/kg harvested within two sessions of leukapheresis sessions—a procedure where white blood cells are separated from a blood sample—indicating that the drug effectively mobilized stem cells. According to ClinicalTrials.gov, the mid-stage study should have been completed last September , though Exicure has neither released complete data for it nor outlined its development roadmap for burixafor. Cancer Reframing Multiple Myeloma: From Fatal to Chronic and Even Curable Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs. January 21, 2025 · 8 min read · Kate Goodwin Read more

Sen. Ron Wyden of Oregon and six other Senate Democrats are seeking clarity on whether there is “any evidence that these deals will benefit American patients and taxpayers in terms of savings to the Medicaid program." Although major pharmaceutical companies have fallen in line with President Donald Trump’s “most favored nation” (MFN) drug pricing agenda, the specifics of their negotiated concessions and the actual impact on medicine affordability in the U.S. remain unclear.Now, amid mounting scrutiny of those MFN deals by patient advocacy groups and others—and on the heels of a late-2025 effort by Democratic lawmakers to suss out the fine details—Democratic Sen. Ron Wyden of Oregon, ranking member of the Senate Finance Committee, is going to drugmakers directly for answers. Backed by six other Senate Democrats, Wyden has sent out 11 letters to as many pharmaceutical makers, seeking clarity on whether there is “any evidence that these deals will benefit American patients and taxpayers in terms of savings to the Medicaid program,” according to a March 6 press release. The senators’ inquiry specifically calls on drugmakers behind MFN agreements to provide information on which of their drugs fall under the accords, what the MFN prices for those drugs are and what state Medicaid programs are actually expected to pay in the wake of the announcements. According to the Senate Finance Committee, letters have been sent out to AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Roche’s Genentech, Gilead Sciences, GSK, Johnson & Johnson, Merck & Co., Novartis and Sanofi.Fierce Pharma has reached out to the companies for comment.  The latest salvo of letters comes after Wyden and other senators made similar requests of Pfizer, AstraZeneca, Novo Nordisk and Eli Lilly in December. Wyden and the other senators’ MFN concerns are driven, at least in part, by Trump’s passing of the Republican reconciliation bill on July 4 last year, which cut nearly $900 billion from the U.S. Medicaid program, according to the letter (PDF). Given the thinner margins upon which state Medicaid programs must now operate, the lawmakers specifically want to know whether “the prices [the companies] will make available on these drugs are actually lower than the net pricing states currently receive on the same products in Medicaid,” the letter continues. Wyden and the senators have given the drugmakers a March 23 deadline to respond, stressing that states need timely access to the information to make budgetary decisions prompted by the loss of Medicaid funding.  Scrutiny intensifies Skepticism of MFN and related ventures, like the government’s cash-pay drug purchasing portal, TrumpRx.gov appears to be mounting among both Trump’s critics and allies.In late January, consumer advocacy group Public Citizen filed a Freedom of Information Act (FOIA) lawsuit against the Department of Health and Human Services in its own bid to extract more information on the government’s opaque MFN agreements. “Trump and RFK Jr. pledged ‘radical transparency,’” Peter Maybarduk, Public Citizen’s access to medicines director, said in a release at the time. “Instead, they’ve given us secret deals with drugmakers.” Maybarduk added that the “secrecy” surrounding the deals makes it impossible to determine their effectiveness in lowering certain drug prices. Meanwhile, some 50 leaders of free-market and conservative organizations wrote a letter (PDF) to Congress in February calling on the lawmakers to reject Trump’s MFN policy, which they suggested would “import socialist price controls and values into our country.” The organizations made their push after Trump’s “Great Healthcare Plan,” unveiled earlier this year, invoked Congress to codify the president’s MFN policies. And last month, John Barkett, a former senior policy advisor in the Biden administration, agreed that more details are needed on the slate of recent government-industry tie-ups. “I think it would be helpful for all parties to reveal what the deals actually say,” Barkett said in a recent interview with Fierce. “In the Oval Office, the administration leaders have gotten up there and said, ‘this is the biggest drug pricing policy deal to ever happen.’ That’s an odd thing to say when you’re not willing to reveal the details of it.”Barket also questioned whether the MFN-negotiated prices might differ from those paid by Medicaid, and how the policy will affect, if at all, people covered by Medicare and commercial insurance. So far, the following Big Pharma companies have signed onto MFN agreements with the White House: AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, BMS, Lilly, Merck KGaA’s EMD Serono, Genentech, Gilead, GSK, J&J, Merck, Novartis, Novo Nordisk, Pfizer and Sanofi.  Though the exact terms remain confidential, the details of the deals as advertised have been broadly similar, winning concessions from drugmakers to discount select medicines’ list prices, broaden direct-to-consumer sales avenues and list certain drugs on TrumpRx.gov. Many companies have pointed to several examples of medicines they plan to discount, but the full scope of the agreements remains unclear. In return for those pledges—typically alongside commitments to invest in new U.S. infrastructure projects—MFN companies have also won immunity to the Trump administration’s pharmaceutical tariff threats. 

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 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 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo