Darolutamide

Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to recruit people at sites across Australia and New Zealand Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases per year, causing almost 400,000 deaths1. Prostate cancer market is approximately $12 billion2 This study marks a key step in RedHill's development of opaganib in oncology, complementing its U.S. Government-supported medical countermeasures and infectious diseases programs TEL AVIV, Israel and RALEIGH, N.C., July 1, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the initiation of patient recruitment into the Phase 2 study evaluating the efficacy of opaganib3 in combination with darolutamide4 in men with metastatic castrate-resistant prostate cancer (mCRPC), sponsored by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd. (ANZUP) in Australia, and supported by Bayer (ETR: BAYN) and Ramsay Hospital Research Foundation. The Company also announced the study will recruit people across at least 10 sites across Australia and New Zealand. Led by Professor Lisa Horvath, from Sydney's Chris O'Brien Lifehouse, and ANZUP, the innovative 60-participant placebo-controlled randomized study is designed to test the potentially enhancing effect of opaganib in overcoming resistance to standard of care androgen receptor pathway inhibition (ARPI) treatment. The unique study will utilize a companion lipid biomarker test (PCPro5) to select mCRPC patients who have poor prognosis to standard of care treatment, and who may benefit from an opaganib + darolutamide combination approach to treatment. The study's primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated. Cancer cells can block apoptosis (programmed cell death), an important cell-level process designed to help the body get rid of unneeded or abnormal/unhealthy cells, which are critical in fighting the spread of cancer. Prior research shows that opaganib enhances androgen receptor signaling inhibitor efficacy in vitro6, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), and may potentially provide the key to overcoming darolutamide resistance in men with mCRPC. Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases per year, causing almost 400,000 deaths every year, while millions more people are living with prostate cancer resulting in a significant burden of disease.7 The global prostate cancer market was worth approximately $12 billion in 2023.8 About the Study The study is a double-blind, placebo-controlled randomized Phase 2 trial, adding opaganib to darolutamide in people with mCRPC and poor prognosis (as defined by plasma lipid signature, PCPro). The target population of the study is people with mCRPC who have had no treatment with newer, potent AR signaling inhibitors including darolutamide, enzalutamide, apalutamide, or abiraterone. 200 people with prostate cancer who are identified as potentially eligible will have a 5-ml plasma sample taken for PCPro testing. Those who are PCPro-positive (estimated 40% of patients) and agree to enter the study will be randomized on a 1:1 ratio to either the darolutamide 600mg bid + placebo (n=30) arm or the darolutamide 600 mg bid + opaganib 500 mg bid (n=30) arm. The study is registered on clinicaltrials.gov (NCT04207255). About Prostate Cancer Prostate cancer is the second most diagnosed cancer in the world with around 1.5 million new cases annually – causing around 400,000 deaths, with millions more people living with prostate cancer, resulting in a significant burden of disease. Globally, the number of cases of prostate cancer increased by almost 120% from 1990 to 20199. When prostate cancer spreads outside of the prostate to other parts of the body (such as the lymph nodes or bones) it is classified as advanced or metastatic prostate cancer10. Five-year survival rates for prostate cancer diagnosed at Stage 1 is 100%; this drops to just 28% for people with Stage 4 (advanced) disease11. About Androgen Receptor Pathway Inhibitors (ARPI) ARPI is a key therapeutic strategy in treating prostate cancer, particularly castration-resistant prostate cancer. These treatments work by blocking the activity of male hormones such as testosterone (androgens), which are implicated in the growth of prostate cancer cells. By disrupting the AR signaling pathway, these therapies aim to slow tumor progression and improve patient outcomes. Key therapeutic options include darolutamide, enzalutamide, (Xtandi®, Pfizer / Astellas) and apalutamide (Erleada®, Johnson and Johnson). About Opaganib (ABC294640) Opaganib, a first-of-its-kind proprietary investigational host-directed and potentially broad-acting orally administered drug with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute radiation syndrome (GI-ARS), chemical exposure indications, COVID-19, Ebola and other viruses as part of pandemic preparedness. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA). Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study. Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants. In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was published in Microorganisms. Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission. Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology, radioprotection, viral, inflammatory, and gastrointestinal indications. About ANZUP ANZUP is the leading cancer-cooperative clinical trials group that brings together all of the professional disciplines and groups involved in researching and treating urogenital cancers and conduct high quality cancer research. ANZUP's mission is to improve the lives of people affected by bladder, kidney, testicular, penile and prostate cancers towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia. About Chris O'Brien Lifehouse and Ramsay Hospital Research Foundation Chris O'Brien Lifehouse is a world-class not-for-profit, comprehensive cancer hospital based in Sydney, Australia. From screening to prevention, diagnosis, treatment and wellness, Chris O'Brien Lifehouse treats all types of cancer, specializing in those that are complex and rare, offering patients every service and therapy they need under one roof. Ramsay Hospital Research Foundation was established in 2017 to enhance healthcare delivery and improve patient outcomes in Australia, guided by a mission to provide better outcomes for its patients, to investigate the diseases and illnesses which affect them and to progress the learning and development of those who care for them. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults12. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Category: R&D 1 Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 2 Global market data provided by GlobalData 3 Opaganib is an investigational new drug, not available for commercial distribution. 4 Darolutamide (Nubeqa®) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, October 2023. 5 PCPro is a proprietary lipid biomarker assay from Chris O'Brien Lifehouse, a not-for-profit comprehensive cancer hospital 6 ANZUP – Data on File 7 Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. 8 Market data provided by GlobalData 9 Weiyu Zhang et al: Global Burden of Prostate Cancer and Association with Socioeconomic Status, 1990–2019: A Systematic Analysis from the Global Burden of Disease Study. J Epidemiol Glob Health. 13: 407–421 (2023). 10 Cancer Council NSW. Advanced Prostate Cancer. 2023 11 . 12 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

iStock, Grandbrothers The FDA delivered two notable approvals for RSV immunization, UroGen overcame a negative advisory committee vote to secure an approval in bladder cancer, and more key regulatory nods from the past month. Moderna Expands mRNA RSV Shot—But CDC Recommendation Still Uncertain The FDA on June 13 signed off on the broader use of Moderna ’s mRNA vaccine mResvia for respiratory syncytial virus, opening up inoculation for at-risk adults aged 18 through 59 years. For analysts at William Blair, however, approval is just the first regulatory hoop the vaccine will have to go through. “In our view, investor focus will likely shift to the CDC’s Advisory Committee on Immunization Practices (ACIP)’s next meeting,” they wrote in a note at the time, noting that the shot—and the broader vaccine market—could be battered by more headwinds still if the ACIP recommends “restrictive” guidelines. Currently, the CDC recommends a narrower use of RSV shots, where blanket vaccination is only recommended in adults 75 and older. In those 60 through 74 years of age, the CDC endorses immunization for those who are at risk of severe RSV. Earlier this month, Health and Human Services Secretary Robert F. Kennedy Jr. purged the ACIP of all 17 members in a move he claimed was “necessary to reestablish public confidence in vaccine science.” The next day, he named eight new panelists , many of whom have a documented history of vaccine skepticism and two who have previously spoken out specifically against the mRNA technology that underpins Moderna’s mResvia. The new committee members met on June 25 and 26 but did not vote on mResvia. The RSV vaccine was first approved in May 2024 for all adults 60 and above. Merck’s RSV Antibody Clears FDA Bar to Challenge Sanofi, AstraZeneca The FDA approved the use of Merck ’s anti-RSV antibody clesrovimab in infants on June 10. Merck will market the therapy under the brand name Enflonsia. The approval covers the use of Enflonsia to prevent RSV-related lower respiratory tract disease in newborns and infants who are entering their first season of circulating respiratory diseases. According to Merck, Enflonsia provides “rapid and durable” RSV protection persisting for five months, the length of a typical RSV season. Enflonsia is dosed at 105 mg regardless of patient weight. Enflonsia’s approval was backed by data from the Phase IIb/III CLEVER study, which found that in preterm and full-term infants up to 1 year, the antibody reduced RSV-associated medically attended lower respiratory infections by 60.5% versus placebo. Enflonsia also cut RSV hospitalizations by 84.3% as compared with placebo. Additional supporting data came from the Phase III SMART trial, which compared Enflonsia against Sobi’s Synagis, which is also a monoclonal antibody designed to prevent RSV. Interim results announced in October 2024 showed that Enflonsia could match Synagis’ safety and efficacy profiles through five months of observation. With Enflonsia, Merck will now go up against Sanofi and AstraZeneca, which own the immunizing antibody Beyfortus. Approved in July 2023 , Beyfortus has since become a top-performing asset for the companies, hitting blockbuster status in its first full commercial year with €1.7 billion (approximately $1.9 billion) in sales. On June 26, the CDC’s Advisory Committee for Immunization Practices gave Merck another win, voting to recommend Enflonsia to cover babies less than eight months who are not protected by maternal antibodies. Bayer Broadens Use of Nubeqa in Prostate Cancer On June 4, the FDA allowed the use of Bayer’s oral androgen receptor blocker Nubeqa for patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of concurrent chemotherapy. Before this approval, Nubeqa could only be used in the castration-sensitive patient population when it was combined with docetaxel, according to its label . The drug, taken twice daily, was originally approved in July 2019 for men whose cancers had yet to metastasize and were resistant to castration before winning an expansion in August 2022 for metastatic hormone-sensitive prostate cancer. Nubeqa’s latest approval was backed by data from the Phase III ARANOTE trial, a randomized, double-blinded and placebo-controlled trial with nearly 670 participants. Patients were given 600-mg Nubeqa on top of androgen deprivation therapy (ADT). Results, published in September 2024, showed that the Nubeqa regimen significantly improved radiographic progression-free survival, resulting in a 46% drop in the risk of disease progression or death as compared with placebo plus ADT. This efficacy was maintained in patients with high-volume mCSPC, who saw a 40% risk reduction, and was improved in those with low-volume disease, in which the risk was reduced by 70%. Nubeqa brought in €1.523 billion, or around $1.75 billion for Bayer in 2024. UroGen Surmounts AdComm Apprehension to Win Bladder Cancer Approval Despite failing to secure the backing of an external panel of advisors, UroGen won the FDA’s approval on June 13 for its intravesical drug mitomycin for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. UroGen will market the drug under the brand name Zusduri. Zusduri is the first FDA-approved therapy for this indication and is meant for use in adults with recurrent disease, according to UroGen’s announcement. The drug, which is administered via a catheter directly into the bladder in an out-patient procedure, will be available “on or around” July 1. The Phase III ENVISION study, which is still ongoing, supported the regulatory decision with a 79.6% complete response rate at three months. The single-arm pivotal trial documented an 80.6% duration of response at 18 months, according to the latest data, released in April. Zusduri’s approval comes as a bit of a surprise, given that the FDA’s Oncologic Drugs Advisory Committee last month recommended against it—though only narrowly so. With a 5–4 split, the independent panel of experts pointed to several issues with UroGen’s application package, including the lack of a completely randomized study and the short follow-up in ENVISION. UroGen has promised to see the ENVISION trial through to completion “to further characterize the clinical benefit of Zusduri” and will provide the FDA with yearly updates regarding the drug’s duration of response for all treated patients with ongoing complete responses. Nuvation Wins First Commercial Approval With Lung Cancer Drug Ibtrozi On June 12, the FDA approved Nuvation Bio’s oral ROS1 blocker taletrectinib, which will be sold as Ibtrozi. The approval covers the drug’s use in non-small cell lung cancer. Ibtrozi is Nuvation’s first commercial product. Ibtrozi’s approval was backed by data from the Phase II TRUST-I and TRUST-II trials, which together account for “one of the largest global clinical trial programs in ROS1+ NSCLC [non-small cell lung cancer] to date,” according to Nuvation’s Wednesday release. Over 300 patients were enrolled across both trials. Results from TRUST-I showed a confirmed overall response rate (cORR) of 90% in patients with no prior exposure to tyrosine kinase inhibitor (TKI). TRUST-II confirmed these findings with an 85% cORR. Because of the single-arm nature of the TRUST program, progression-free survival isn’t included in Ibtrozi’s label. The TRUST studies also specifically looked at the benefits of Ibtrozi in patients with brain metastases—which Nuvation on Wednesday called “among the most common and devastating complications” in ROS1-positive NSCLC—and found high rates of treatment response. In patients with measurable brain metastasis at baseline, Ibtrozi demonstrated an intracranial response of 73% in the TKI-naïve subgroup and 63% in those who had previously been exposed to TKI treatments. Analysts at Jefferies at the time said that while Ibtrozi’s approval was positive for Nuvation, “patience may be needed by investors with several quarters to execute and demonstrate strong launch momentum.” BeOne Secures Approval for Twice-Daily Brukinsa Schedule BeOne—formerly known as BeiGene—received FDA approval on June 12 for a new tablet formulation of the tyrosine kinase inhibitor Brukinsa to be taken twice-daily. This label expansion covers all approved indications of Brukinsa , including mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma and Waldenström’s macroglobulinemia. “The recommended dose of Brukinsa remains at 320 mg daily,” BeOne noted in a news release announcing the approval. The new formulation delivers a 160-mg dose of the drug in each tablet, giving patients the option to “take two tablets daily rather than four of the current 80 mg capsules.” With the tablet nod, Brukinsa has become “the only BTK inhibitor to offer the flexibility of once or twice daily dosing,” with some leeway to adjust the schedule based on patient needs, the company said. Supporting the FDA’s decision are bioequivalence data generated from two Phase I crossover trials of healthy adults, which showed that the tablets are as safe and as effective as the capsules. Matt Shaulis, North America general manager of BeOne, said the tablet approval makes “treatment simpler and more convenient” for patients. BeOne expects to completely replace the 80-mg capsules with the 160-mg tablets by October 2025. AbbVie’s Mavyret Becomes First Antiviral for Acute Hepatitis C Also notching a notable regulatory nod this month is AbbVie, which on June 11 won the FDA’s first approval for an acute hepatitis C virus (HCV) drug. The approval of Mavyret, an oral antiviral, was supported by data from a Phase III single-arm prospective trial that enrolled nearly 300 treatment-naïve adults who had acute infection. Mavyret was given once-daily for eight weeks. Results, which are reflected in the drug’s label , show that Mayret elicited a sustained virological response of 96% 12 weeks post-treatment. None of the study participants experienced virologic failure. According to AbbVie, the label expansion allows doctors to treat patients “immediately at the time of diagnosis.” While hepatitis C infection is a curable disease, it often goes undiagnosed, as per the pharma’s news release announcing the approval. “If left untreated, people with acute HCV could progress to chronic disease, including liver-related complications” like cancer and cirrhosis. Mavyret is a direct-acting antiviral tablet that delivers a combination of drugs: glecaprevir , a protease inhibitor that disrupts the replication of the virus’ genetic material, and pibrentasvir , which blocks viral RNA replication while also preventing the formation of the viral particle itself. First approved in August 2017 , Mavyret is the first-ever product to be indicated for all types of HCV. Mavyret brought in roughly $1.3 billion in 2024 , a nearly 7% decline year-on-year. AstraZeneca, Daiichi Sankyo Earn Accelerated Approval for Datroway in NSCLC Datroway, an antibody-drug conjugate jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, can now be used for patients with advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. The FDA granted the biologic accelerated approval in this indication on June 24. The regulatory decision was backed by data from a subgroup analysis of the Phase II TROPION-Lung05 study, also supported by findings from the Phase III TROPION-Lung01 trial. Findings from these studies showed that Datroway elicits a confirmed objective response rate of 45% in patients who had undergone prior lines of treatment. This includes 4.4% complete responses and 40% partial responses. Median duration of response was 6.4 months. As per the terms of the FDA’s accelerated pathway, AstraZeneca and Daiichi Sankyo will need to validate Datroway’s clinical benefit in future confirmatory trials to maintain this approval. Datroway won its first U.S. approval in January 2025, allowing its use in patients with unresectable or HR-positive, HER2-negative breast cancer who had been previously treated. The therapy works by binding to TROP2, a surface protein found on many tumor cells, and delivering its topoisomerase I inhibitor payload, according to its label . This mechanism damages DNA in cancer cells, ultimately leading to their death.