Daiichi Sankyo Company, Limited manufactures and sells pharmaceutical products in Japan, the United States, Europe, and internationally. Its portfolio includes Enhertu for HER2-positive and low breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors; Turalio for symptomatic TGCT; Vanflyta for acute myeloid leukemia; Injectafer for iron deficiency; and DATROWAY for breast cancer and NSCLC. It also offers antihypertensives, cholesterol-lowering agents, antiplatelet agents, diabetes treatments, migraine therapies, osteoporosis and bone complication treatments, neuropathic pain relief, iron deficiency anemia treatments, and anti-seizure medications, as well as vaccines for COVID-19, influenza, measles/rubella, and mumps. The company has a strategic collaboration with Lunit Inc. for biomarker discovery and translational research. Founded in 1899, it is headquartered in Chuo, Japan.
Daiichi Sankyo's cancer drugs win approvals, trials and NHS access
▲
Datroway approved in EU for first-line TNBC Datroway became the first TROP2 antibody-drug conjugate approved in the EU for first-line triple-negative breast cancer, with a 5-month overall survival benefit. This opens a new, large market and supports the drug's rapid sales growth, pushing 4568.JP up.
New approval directly expands the commercial opportunity for a key growth drug.
▲
Full-year guidance raised on 21% revenue jump First-quarter revenue rose 21% to 574.7 billion yen, led by Enhertu and Datroway, and management raised full-year revenue and profit forecasts. Stronger U.S. sales and favorable currency rates underpin the upgrade, boosting investor confidence in 4568.JP.
Guidance raise signals stronger-than-expected business momentum and earnings power.
▲
Enhertu shows strong first-line lung cancer data Enhertu cut the risk of progression or death by 37% versus standard care in first-line HER2-mutant lung cancer, with median progression-free survival of 14.3 months. Positive phase 3 results raise the chance of expanded approval, adding to 4568.JP's long-term growth outlook.
Late-stage trial success increases the probability of a new major indication for Enhertu.
▲
NHS England reimburses Enhertu for HER2-low breast cancer England's NHS reversed an earlier rejection and will fund Enhertu for about 1,000 women a year with HER2-low metastatic breast cancer. As co-developer, Daiichi Sankyo shares in the expanded access, though confidential discounts mean the exact financial benefit is unclear.
Reimbursement win widens patient access and commercial reach for a core drug.
Q3 2026
▲3▼1
Daiichi Sankyo's ADC Franchise Expands with EU Approvals and Strong Revenue
▲
EU Approvals for Datroway and Enhertu Datroway received EU first-line TNBC approval, while Enhertu gained EU tumor-agnostic approval, triggering a $25M AstraZeneca milestone. These expand treatment options and validate the ADC platform.
These approvals are major regulatory wins that open new markets and drive revenue potential.
▲
Enhertu Reimbursement and Trial Success Enhertu secured NHS England reimbursement for HER2-low breast cancer after earlier rejection and showed strong first-line lung cancer data. This improves patient access and supports future growth.
Reimbursement and positive trial results directly impact sales and market confidence.
▲
Strong Q1 Revenue and Raised Guidance Q1 revenue jumped 21% to ¥574.7B, prompting raised full-year guidance. This reflects robust business performance and management confidence.
Revenue growth and guidance raise are key financial indicators that drive investor sentiment.
▼
Reimbursement Uncertainty and Undisclosed Economics The NHS pricing deal could still fall through, and confidential discounts obscure the exact financial benefit of expanded access. These factors temper the positive outlook.
These risks could limit the financial upside from approvals and reimbursements.
News & notes moving4568.JP
United StatesJapanUnited Kingdom
Biotech & Genomic Medicine▲4
Summit Therapeutics, AstraZeneca and Daiichi Sankyo to Study Ivonescimab Plus Datroway Combos
Summit Therapeutics has signed a clinical collaboration with AstraZeneca and its Japan-based partner Daiichi Sankyo to evaluate ivonescimab in combination with the antibody-drug conjugate Datroway, also known as datopotamab deruxtecan, across multiple solid tumors including breast and lung cancers. The collaboration is expected to initially focus on a phase III study in first-line triple-negative breast cancer, expanding ivonescimab's development into a new tumor type. Under the agreement, each company will supply its respective drug, AstraZeneca or Daiichi will sponsor the planned studies, and the companies will share study costs while retaining development and commercial rights to their own therapies. The Datroway collaboration builds on the larger deal between AstraZeneca and Summit announced in the last week, under which AstraZeneca agreed to invest $2 billion in Summit to accelerate development of ivonescimab, with the companies also set to evaluate ivonescimab alongside AstraZeneca's investigational Claudin-18.2-targeted ADC sonesitatug vedotin, or Sone-Ve, in gastrointestinal cancers. An FDA filing is under review seeking approval for ivonescimab plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who had progressed following EGFR-TKI treatment, with a final decision expected by Nov. 14, 2026.
Biotech & Genomic Medicine › Oncology Therapeutics ▲Capital
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Capital
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Capital
4568.JP · Technology · Positive Daiichi Sankyo's Datroway (datopotamab deruxtecan) will be evaluated in combination with ivonescimab across multiple solid tumors, including a phase III triple-negative breast cancer study
AZN.LSE · Technology · Positive AstraZeneca will co-sponsor and supply its Datroway ADC in a new phase III combination study with ivonescimab, expanding its oncology pipeline
AstraZeneca Invests $2 Billion in Summit Therapeutics for Ivonescimab Trials
AstraZeneca PLC, Daiichi Sankyo and Summit Therapeutics announced clinical collaboration agreements to test ivonescimab in combination with Datroway and sonesitatug vedotin across multiple tumour types, starting with a planned Phase III trial in first-line triple-negative breast cancer and gastrointestinal cancer. AstraZeneca's approximately US$2.00 billion equity investment via convertible preferred stock, alongside the co-funded oncology trials, prices the preferred stock at an implied US$18.36 per common share and targets roughly a 12% ownership stake in Summit. All parties retain full rights to their respective medicines. The investment strengthens Summit's funding and combination profile ahead of the HARMONi and HARMONi-3 readouts, though the U.S. FDA decision on the HARMONi BLA remains the key near-term catalyst and central source of risk. Summit's narrative projects $1.3 billion revenue and $223.0 million earnings by 2029, while some optimistic analysts model about US$2.7 billion of revenue and nearly US$289 million of earnings by 2029.
Biotech & Genomic Medicine › Oncology Therapeutics ▲Capital
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Capital
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Capital
AZN.LSE · Capital · Positive AstraZeneca makes a ~$2.00 billion equity investment in Summit via convertible preferred stock and co-funds ivonescimab combination trials.
4568.JP · Technology · Neutral Daiichi Sankyo is a party to the clinical collaboration testing ivonescimab with its Datroway and sonesitatug vedotin, but no financial or efficacy outcome is disclosed.
Merck and Daiichi Sankyo Withdraw US Filing for Ifinatamab Deruxtecan in Small-Cell Lung Cancer
Merck & Co., Inc. and Daiichi Sankyo announced on September 25 that they voluntarily withdrew the U.S. application for ifinatamab deruxtecan in adults whose extensive-stage small-cell lung cancer progressed during or after platinum-based chemotherapy, after FDA discussions concluded the submitted evidence, including Phase 2 results, did not satisfy accelerated-approval requirements. The withdrawal removes a previously announced October 10, 2026 FDA target decision date, and no replacement filing timetable was announced. The partners pointed to tumor activity data reported in September 2025 showing a confirmed objective response rate of 48.2% among 137 patients receiving 12 mg/kg in IDeate-Lung01, with a median response duration of 5.3 months, though the trial did not compare the drug against standard chemotherapy. Merck continues development through the randomized Phase 3 IDeate-Lung02 trial, which compares ifinatamab deruxtecan with physician-selected chemotherapy after one prior platinum-based regimen and where Daiichi Sankyo said enrollment was nearly complete, alongside continuing Phase 3 studies in prostate and esophageal cancers. Safety remains central: in the Phase 2 dataset, Grade 3 or higher treatment-related adverse events occurred in 36.5% of patients, and independently adjudicated treatment-related interstitial lung disease or pneumonitis occurred in 12.4%, including two fatal cases, while the FDA placed IDeate-Lung02 on partial clinical hold in December 2025 after more fatal interstitial lung disease events than expected, a hold lifted in January 2026 following added safeguards.
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▼Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▼Regulation
4568.JP · Regulation · Negative Daiichi Sankyo's partnered US filing for ifinatamab deruxtecan was withdrawn after FDA concluded the Phase 2 evidence did not meet accelerated-approval requirements.
MRK · Regulation · Negative Merck and Daiichi Sankyo voluntarily withdrew the US accelerated-approval filing for ifinatamab deruxtecan in small-cell lung cancer after FDA discussions found the evidence insufficient.
AstraZeneca and Daiichi Sankyo's Enhertu Approved for NHS Use in England
AstraZeneca and Daiichi Sankyo's Enhertu has been cleared for use by England's National Health Service for patients with HER2-low metastatic breast cancer, reversing an earlier NICE decision that rejected funding on cost-effectiveness grounds. NICE's revised recommendation follows changes to drug valuation methods and a U.S.-UK agreement aimed at aligning medicine prices, and around 1,000 women in England are expected to benefit annually. Enhertu carries a list price of £1,455 per 100 mg vial, although the financial terms agreed with NICE were not disclosed, and NICE cited clinical evidence showing a six-month survival benefit for some patients. The decision expands access in one of Europe's largest healthcare markets and comes as Enhertu is already a significant growth driver: combined sales reported by AstraZeneca and Daiichi Sankyo reached $2.96 billion in the first half of 2026, up 29% from $2.29 billion a year earlier, while AstraZeneca's own H1 alliance revenue from Enhertu rose to $1.06 billion from $834 million. In Europe, AstraZeneca reported $401 million of Enhertu revenue, up 28%, and combined global sales increased 36% in FY2025 to $4.98 billion, with AstraZeneca's alliance revenue reaching $1.80 billion versus $1.44 billion in 2024. The direct financial contribution from England may remain relatively limited given the roughly 1,000 patients expected annually and the undisclosed commercial terms, making the incremental revenue, margin, or cash-flow benefit difficult to quantify.
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
4568.JP · Regulation · Positive Enhertu, co-developed with AstraZeneca, gained NHS England approval for HER2-low metastatic breast cancer, expanding access to the drug.
AZN.LSE · Regulation · Positive NICE reversed its rejection and approved NHS funding for Enhertu in HER2-low metastatic breast cancer, expanding access in England.
AstraZeneca and Daiichi Sankyo Report First Phase III Win for HER2-Directed Lung Cancer Drug
AstraZeneca and Daiichi Sankyo reported DESTINY-Lung04 Phase III results showing ENHERTU delayed disease progression in HER2-mutant advanced NSCLC versus standard therapy, with 14.3 months median progression free survival and a 37% risk reduction versus pembrolizumab plus chemotherapy. Long-term follow-up data for TAGRISSO indicated eight-year survival benefits in early-stage EGFR-mutated lung cancer patients already on treatment protocols. Tozorakimab emerged as the first biologic to show efficacy in reducing exacerbations across a broad chronic obstructive pulmonary disease population in late-stage trials, with a 29% to 34% exacerbation reduction. Management has pointed to more than US$10b in potential peak risk adjusted revenue from new drugs, and investors will focus on US and EU COPD approval decisions ahead of the first quarter of 2027 Prescription Drug User Fee Act date. The article was produced by Simply Wall St.
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
4568.JP · Technology · Positive Daiichi Sankyo co-developed ENHERTU, which showed a 37% risk reduction in HER2-mutant advanced NSCLC in DESTINY-Lung04.
AZN.LSE · Technology · Positive ENHERTU Phase III win in HER2-mutant NSCLC plus tozorakimab COPD efficacy and Tagrisso long-term survival data strengthen AstraZeneca's pipeline.
Diabetic Nephropathy Market to Reach $8.8B by 2025, Grow 5% CAGR to 2036
The diabetic nephropathy and diabetes kidney disease market across the seven major markets is valued at approximately USD 8.80 billion in 2025 and is projected to grow at a compound annual growth rate of about 5% from 2026 to 2036, according to a new report from ResearchAndMarkets.com. The total prevalent DKD population in the 7MM is estimated at nearly 34 million cases in 2025, with the United States accounting for nearly 15 million cases and representing the largest regional market. Approximately 70% of US DKD cases occur among individuals aged 60 years and older. Antidiabetic therapies generate the highest DKD-related revenue across the 7MM. Key marketed therapies include JARDIANCE from Boehringer Ingelheim and Eli Lilly, KERENDIA from Bayer, and FARXIGA/FORXIGA from AstraZeneca. In March 2026, a Phase III study of KERENDIA met its primary endpoint in chronic kidney disease patients, showing a statistically significant improvement in estimated glomerular filtration rate slope versus placebo. Emerging pipeline candidates include esaxerenone from Daiichi Sankyo, SER150 from Serodus, bremelanotide from Palatin Technologies, and INV-202 from Novo Nordisk and Inversago Pharma. The report highlights persistent unmet needs such as limited disease-modifying therapies, cardiovascular risk, and delayed diagnosis, creating opportunities for differentiated treatments.
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Demand
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Demand
Boehringer Ingelheim International GmbH · Demand · Positive JARDIANCE is a key marketed DKD therapy generating the highest DKD-related revenue across the 7MM.
4568.JP · Technology · Positive Esaxerenone is listed as an emerging pipeline candidate in the diabetic nephropathy/DKD market, a potential opportunity.
BAYN.XETRA · Technology · Positive Phase III study of KERENDIA met its primary endpoint in chronic kidney disease, improving eGFR slope versus placebo.
Serodus · Technology · Positive SER150 is named as an emerging pipeline candidate for diabetic nephropathy.
AZN.LSE · · Neutral FARXIGA/FORXIGA is named as a key marketed DKD therapy; no new AstraZeneca-specific news.
LLY · · Neutral JARDIANCE, co-marketed with Boehringer Ingelheim, is listed as a key marketed DKD therapy; no new company-specific development.
EU Approves Enhertu Plus Pertuzumab as First-Line HER2 Positive Breast Cancer Treatment
The European Commission has approved Enhertu in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2 positive breast cancer, marking the first new regimen in over a decade for this indication. The approval is based on the DESTINY-Breast09 phase 3 trial, which showed that the combination reduced the risk of disease progression or death by 44% versus THP, with a median progression-free survival of 40.7 months compared to 26.9 months. This is the second approval for Enhertu in the EU in two months, following a recent tumor-agnostic approval. Daiichi Sankyo and AstraZeneca jointly developed the drug, and AstraZeneca will pay Daiichi Sankyo a $100 million milestone payment following this approval. The combination is now approved in more than 40 countries worldwide for this indication.
Daiichi Sankyo and AstraZeneca Start Phase 3 Trial of Datroway in Urothelial Cancer
Daiichi Sankyo and AstraZeneca have dosed the first patient in the TROPION-Urothelial04 phase 3 trial, evaluating Datroway plus rilvegostomig or Datroway monotherapy versus current standard of care as adjuvant treatment for patients with high-risk muscle invasive urothelial cancer. The trial will enroll approximately 915 patients across Asia, Europe, North America, Oceania, and South America, with disease-free survival as the primary endpoint. This is the second pivotal trial for Datroway in urothelial cancer, following encouraging results from earlier studies. Muscle invasive urothelial cancer represents about 30% of all urothelial cancer cases, and there are currently no TROP2-directed medicines approved for this disease.
ENHERTU improves progression-free survival in first-line HER2-mutant lung cancer trial
AstraZeneca and Daiichi Sankyo announced that ENHERTU demonstrated a statistically significant and clinically meaningful improvement in progression-free survival versus the global standard of care in the DESTINY-Lung04 Phase III trial for first-line treatment of HER2-mutant advanced non-small cell lung cancer. The trial compared ENHERTU against platinum-pemetrexed doublet chemotherapy plus pembrolizumab in 454 patients with unresectable, locally advanced or metastatic non-squamous NSCLC. ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over the standard of care in this setting, and the safety profile was consistent with its known profile with no new safety concerns. The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Innovent and Daiichi Sankyo sign exclusive China deal for VANFLYTA commercialization
Innovent Biologics has entered into an exclusive agreement with Daiichi Sankyo to commercialize the FLT3 inhibitor VANFLYTA in China. Under the deal, Innovent gains marketing and distribution rights while Daiichi Sankyo retains manufacturing and supply responsibilities. VANFLYTA is approved in Japan, the U.S., and Europe for relapsed or refractory FLT3-ITD positive acute myeloid leukemia, an aggressive blood cancer with poor prognosis. Innovent will leverage its Chinese commercial infrastructure to expand access, and Daiichi Sankyo will receive upfront and milestone payments plus royalties on net sales.
Daiichi Sankyo Lifts Full-Year Forecasts After 21% Revenue Jump
Daiichi Sankyo reported a 21.1% year-over-year increase in first-quarter fiscal 2026 revenue to 574.7 billion yen, driven by its oncology portfolio, and raised its full-year guidance. Operating profit fell 12.0% to 85.1 billion yen due to EU Specialty Business restructuring costs. Enhertu revenue, including milestone payments, surged 48.9% to 239.8 billion yen, while Datroway revenue jumped 176.4% to 23.9 billion yen. The company now expects full-year revenue of 2.34 trillion yen, up from a prior forecast of 2.28 trillion, and operating profit of 320.0 billion yen, up from 315.0 billion. The upward revision reflects stronger anticipated U.S. sales and favorable foreign exchange rates.
Datroway Approved in EU as First-Line TNBC Therapy with Overall Survival Benefit
Datroway has been approved in the European Union as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval is based on the TROPION-Breast02 phase 3 trial, where Datroway demonstrated a statistically significant and clinically meaningful 5.0 month improvement in median overall survival versus investigator's choice of chemotherapy, with a median overall survival of 23.7 months compared to 18.7 months. Datroway also reduced the risk of disease progression or death by 43% and achieved an objective response rate of 62.5% versus 29.3% for chemotherapy. The safety profile included serious adverse reactions in 17% of patients, with one fatality attributed to interstitial lung disease/pneumonitis. Datroway is now the only TROP2 directed antibody drug conjugate approved in the EU with an overall survival benefit in the first-line setting, and it has been included in ESMO Clinical Practice Guidelines as a Category IA first-line treatment option.
Enhertu plus pertuzumab recommended for EU approval as first-line HER2 positive metastatic breast cancer treatment
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Enhertu plus pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2 positive breast cancer. The positive opinion is based on the DESTINY-Breast09 phase 3 trial, which showed the combination reduced the risk of disease progression or death by 44% versus standard-of-care taxane, trastuzumab and pertuzumab, with a median progression-free survival of 40.7 months compared to 26.9 months. If approved by the European Commission, this would be the first new first-line treatment in the EU for this indication in more than a decade. Enhertu is a HER2 directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca. The safety profile was consistent with the known profiles of each individual treatment, with the most common grade 3 or higher treatment-related adverse events being neutropenia, hypokalemia, and anemia.
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
4568.JP · Demand · Positive Enhertu plus pertuzumab recommended for EU approval as first-line HER2+ metastatic breast cancer treatment, expanding market opportunity.
AZN.LSE · Demand · Positive Enhertu plus pertuzumab recommended for EU approval as first-line HER2+ metastatic breast cancer treatment, expanding market opportunity.
Nvidia CEO Huang unveils broad AI partnerships across Japan's key industries
Nvidia CEO Jensen Huang unveiled a broad slate of AI products, partnerships, and customer deployments at the company's Japan AI event in Tokyo on July 15. The announcements spanned physical AI, healthcare, financial services, quantum computing, automotive, manufacturing, and gaming, highlighting Nvidia's push to position its technologies at the forefront of Japan's next-generation AI infrastructure. In physical AI and robotics, Nvidia launched Cosmos 3 Edge for on-device vision reasoning, and companies including FANUC, Fujitsu, Hitachi, Kawasaki Heavy Industries, Kubota, NEC, SoftBank, Sony Group, and Yaskawa Electric plan to join the Nvidia Cosmos Coalition to develop open physical AI models. In healthcare, Astellas Pharma, Eisai, Daiichi Sankyo, Ono Pharmaceutical, and Takeda Pharmaceutical are deploying Nvidia BioNeMo for AI-powered drug discovery, while Canon and Fujifilm introduced Nvidia-powered next-generation CT systems, and Kawasaki Heavy Industries is advancing AI-enabled surgical and hospital robots. In financial services, Mizuho Financial plans Japan's largest on-premises AI factory for banking, Sumitomo Mitsui Financial has deployed an AI factory through Japan Research Institute, and Rakuten Bank is developing AI transaction foundation models using Nvidia Agent Toolkit. Huang emphasized that the next wave of AI will be physical AI—robots, factories, vehicles, and industrial systems that can perceive, reason, and act in the real world—and said Japan's leadership in robotics, manufacturing, and precision engineering positions it to play a leading role in this transition.
Artificial Intelligence › Agentic AI & Autonomous Workflows ▲Technology
Robotics & Physical AI › Surgical & Medical Robotics ▲Technology
Artificial Intelligence › Edge & On-device AI Silicon ▲Technology
Artificial Intelligence › AI Applications & Copilots Competition
NVDA · Demand · Positive Nvidia CEO unveils broad AI partnerships across Japan's key industries, driving demand for Nvidia's AI products.
8411.JP · Demand · Positive Mizuho Financial plans Japan's largest on-premises AI factory for banking using Nvidia, a major deployment.
4502.JP · Demand · Positive Takeda Pharmaceutical is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
4523.JP · Demand · Positive Eisai is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
4528.JP · Technology · Positive Ono Pharmaceutical is deploying Nvidia BioNeMo for AI-powered drug discovery.
4568.JP · Demand · Positive Daiichi Sankyo is deploying Nvidia BioNeMo for AI-powered drug discovery, indicating new demand for its AI capabilities.
AstraZeneca and Daiichi Sankyo near UK pricing deal for breast cancer drug Enhertu
AstraZeneca and Daiichi Sankyo are closing in on a pricing deal with England’s health spending watchdog to offer their breast cancer therapy Enhertu through the National Health Service. The National Institute for Health and Care Excellence previously deemed Enhertu too costly for NHS use, but nearly 1,000 women in England and Wales with breast cancer could benefit if a deal is finalized in line with the recent U.S.–U.K. trade agreement that raised cost-effectiveness thresholds for new medicines. Enhertu is already available in more than 20 EU nations, and NHS England would receive a lower price than many other European countries if an agreement is reached. However, a potential deal could still fall apart depending on factors such as anticipated changes to the U.K. government, according to people familiar with the matter. Spokespersons for AstraZeneca and Daiichi Sankyo said discussions are ongoing with NHS England and NICE to make Enhertu available to women with metastatic breast cancer whose tumors express low levels of HER2 protein.
AstraZeneca's Enhertu wins EU approval as first tumor-agnostic ADC for HER2-positive solid tumors
AstraZeneca and Daiichi Sankyo announced that the European Commission has approved Enhertu as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors, marking the drug's sixth indication in the European Union and establishing it as the first HER2-targeted therapy and antibody-drug conjugate to receive a tumor-agnostic indication in the region. The approval triggers a $25 million milestone payment from AstraZeneca to Daiichi Sankyo under their collaboration agreement. Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of the partners' other antibody-drug conjugate, Datroway, as a first-line monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer who are ineligible for PD-1/PD-L1 inhibitor therapy, which would make it the first TROP2-directed ADC in the EU for this population. Datroway was approved for the same first-line triple-negative breast cancer indication in the United States in May and is under regulatory review in several additional markets, including China and Japan.
AstraZeneca's Enhertu wins EU approval as first tumor-agnostic ADC for HER2-positive solid tumors
AstraZeneca and Daiichi Sankyo announced that the European Commission has approved their antibody-drug conjugate Enhertu as a monotherapy for previously treated adults with unresectable or metastatic HER2-positive solid tumors, marking the first HER2-targeted therapy and ADC to receive a tumor-agnostic indication in the European Union. The approval, Enhertu's sixth in the EU, was based on positive data from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 studies showing clinically meaningful responses across a broad range of tumors. Under the collaboration agreement, AstraZeneca will pay Daiichi Sankyo a $25 million milestone payment. Separately, the EMA's CHMP recommended approval of the partners' other ADC, Datroway, as a first-line monotherapy for unresectable or metastatic triple-negative breast cancer in patients ineligible for PD-1/PD-L1 inhibitor therapy, supported by the TROPION-Breast02 study which met its primary endpoints of overall survival and progression-free survival versus chemotherapy.
Datroway Recommended for EU Approval as First-Line Treatment for Metastatic Triple Negative Breast Cancer
Datroway has been recommended for approval in the European Union as a first-line treatment for adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for immunotherapy. The Committee for Medicinal Products for Human Use of the European Medicines Agency based its positive opinion on the TROPION-Breast02 phase 3 trial, where Datroway showed a statistically significant and clinically meaningful 5.0-month improvement in median overall survival versus chemotherapy, with a median overall survival of 23.7 months compared to 18.7 months. Datroway also reduced the risk of disease progression or death by 43 percent, with a median progression-free survival of 10.8 months versus 5.6 months for chemotherapy. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations. Datroway is a TROP2 directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca.
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
4568.JP · Technology · Positive Datroway, discovered by Daiichi Sankyo, recommended for EU approval as first-line treatment for metastatic triple negative breast cancer.
AZN.LSE · Technology · Positive Datroway, jointly developed with AstraZeneca, recommended for EU approval as first-line treatment for metastatic triple negative breast cancer.
Japan
