AstraZeneca and Daiichi Sankyo\u2019s DATROWAY is the only TROP2-directed antibody drug conjugate to prolong overall survival in this setting vs. chemotherapy, with an unprecedented median overall survival of approximately two years based on the TROPION-Breast02 Phase III trial<\/i><\/b><\/p>\n
DATROWAY has the potential to become the new standard of care in this setting<\/i><\/b><\/p>\n
WILMINGTON, Del.–(BUSINESS WIRE<\/a>)– \nThe approval follows Priority Review<\/a> by the Food and Drug Administration (FDA) based on results from the TROPION-Breast02 Phase III trial which were presented<\/a> at the 2025 European Society for Medical Oncology Congress and published in Annals of Oncology<\/i><\/a>.<\/i><\/p>\n \nTiffany A. Traina, MD, FASCO, Section Head, Triple-Negative Breast Cancer Clinical Research Program, Memorial Sloan Kettering Cancer Center and investigator for TROPION-Breast02, said: \u201cDatopotamab deruxtecan is the first and only medicine to significantly prolong overall survival in the 1st-line setting compared to chemotherapy in patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy. This approval will bring a much-needed treatment option for these patients.\u201d<\/p>\n \nArlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation, said: \u201cFor seven out of 10 patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy, chemotherapy has remained the only treatment option. Today\u2019s approval of DATROWAYmeans that for the first time, these patients will have a new standard of care beyond traditional chemotherapy at the outset of their treatment.\u201d<\/p>\n \nDave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: \u201cTriple-negative breast cancer is notoriously difficult to treat. Patients with metastatic disease, especially those who are unable to receive immunotherapy, urgently need more effective, durable and tolerable treatment options, which extend survival. With today\u2019s approval, we are proud to bring DATROWAYto a broad population of advanced triple-negative breast cancer patients and we continue to study its promise as a mainstay treatment across tumors, stages and settings.\u201d<\/p>\n \nKen Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc., said: \u201cAs the first antibody drug conjugate to demonstrate a median overall survival of two years in the 1st-line metastatic setting of triple-negative breast cancer, DATROWAY has the potential to redefine the treatment landscape for these patients. With this approval, DATROWAY is now approved for three indications in the US, including two for breast cancer, underscoring its potential to play an important role across tumor types.\u201d<\/p>\n \nIn the trial, DATROWAY demonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival (OS) (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.64-0.98; p=0.0290) and a 43% reduction in patients\u2019 risk of disease progression or death (HR 0.57; 95% CI 0.47-0.69; p<0.0001) compared to chemotherapy as 1st-line treatment in this patient population. DATROWAY was also associated with more robust treatment responses, including an objective response rate (ORR) of 64% compared to an ORR of 30% with chemotherapy.1<\/sup><\/p>\n \nThe safety profile of DATROWAY in TROPION-Breast02 was consistent with previous clinical trials of DATROWAY in breast cancer.<\/p>\n \nThis application was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. As part of Project Orbis, reviews are ongoing in Australia, Canada, Singapore and Switzerland. This initiative is designed to bring effective cancer treatments to patients as early as possible. Additional reviews are underway in the EU, China and Japan.<\/p>\n \nBased on the results of TROPION-Breast02, datopotamab deruxtecan (DATROWAY) has been included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae<\/sup>) as a Category 1 Preferred 1st-line treatment option for patients with metastatic TNBC who are not candidates for immunotherapy. See NCCN Guidelines\u00ae<\/sup> for detailed recommendations.2<\/sup><\/p>\n \nDATROWAY is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.<\/p>\n INDICATION AND IMPORTANT SAFETY INFORMATION FOR DATROWAY\u00ae<\/sup> (datopotamab deruxtecan-dlnk) This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.<\/p>\n<\/li>\n<\/ul>\n Important Safety Information<\/b><\/p>\n Warnings and Precautions Locally Advanced or Metastatic NSCLC Unresectable or Metastatic Breast Cancer \nPatients were excluded from clinical studies for a history of ILD\/pneumonitis requiring treatment with steroids or for ongoing ILD\/pneumonitis.<\/p>\n \nMonitor patients for new or worsening respiratory symptoms indicative of ILD\/pneumonitis (e.g., dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD\/pneumonitis, consider corticosteroid treatment (e.g., \u22650.5 mg\/kg\/day prednisolone or equivalent). For symptomatic ILD\/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (e.g., \u22651 mg\/kg\/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.<\/p>\n \nWithhold DATROWAY in patients with suspected ILD\/pneumonitis and permanently discontinue DATROWAY if ><\/span>Grade 2 ILD\/pneumonitis is confirmed.<\/p>\n Ocular Adverse Reactions \nIn the pooled safety population, ocular adverse reactions occurred in 38% of patients treated with DATROWAY. Forty-two patients (3.1%) experienced Grade 3 ocular adverse reactions, which included keratitis and dry eye, and four patients (0.3%) experienced a Grade 4 ocular adverse reaction of keratitis, corneal epithelium defect, corneal lesion, and conjunctival hemorrhage. The most common (\u22655%) ocular adverse reactions were dry eye (18%), keratitis (16%), increased lacrimation (6%), and conjunctivitis (5%). The median time to first onset for ocular adverse reactions was 2.3 months (range: 0.03 months to 30 months) and with a median duration of 2.3 months (range: 0.03 months to 19.5 months). Of the patients who experienced ocular adverse reactions, 39% had complete resolution, and 8% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to dosage interruption in 4.3% of patients, dosage reductions in 2.8% of patients, and permanent discontinuation of DATROWAY in 0.9% of patients.<\/p>\n \nPatients with clinically significant corneal disease were excluded from clinical studies.<\/p>\n \nAdvise patients to use preservative-free lubricant eye drops at least four times daily and as needed for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional.<\/p>\n \nRefer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, at end of treatment, and as clinically indicated. While on treatment, conduct visual acuity testing and slit lamp examination every 3 cycles.<\/p>\n \nPromptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, withhold, reduce the dose, or permanently discontinue DATROWAY based on severity.<\/p>\n Stomatitis \nIn the pooled safety population, stomatitis occurred in 63% of patients treated with DATROWAY, including 8% of patients with Grade 3 events and one patient with a Grade 4 reaction. The median time to first onset of stomatitis was 0.5 months (range: 0.03 months to 19.8 months) and with a median duration of 1.1 months (range: 0.03 months to 33.2 months). Stomatitis led to dosage interruption in 5% of patients, dosage reductions in 11% of patients, and permanent discontinuation of DATROWAY in 0.4% of patients.<\/p>\n \nIn patients who received DATROWAY in TROPION-Breast01 and TROPION-Breast02, 39% and 51% respectively used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis\/oral mucositis at any time during the treatment.<\/p>\n \nAdvise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY.<\/p>\n \nMonitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue DATROWAY.<\/p>\n Embryo-Fetal Toxicity \nAdvise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose.<\/p>\n Adverse Reactions Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer \nThe median age was 63 years (range: 36 to 81), 56% of patients were <65 years, 62% of patients were female; 66% were Asian, 26% were White, 0.8% were Black, 6% were other races; and 2.4% were of Hispanic ethnicity.<\/p>\n \nSerious adverse reactions occurred in 26% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were COVID-19 (4%), stomatitis (2.4%), and pneumonia (1.6%). Fatal adverse reactions occurred in 1.6% of patients who received DATROWAY, due to death not otherwise specified.<\/p>\n \nPermanent discontinuation of DATROWAY due to an adverse reaction occurred in 8% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >1% of patients included ILD\/pneumonitis (2.4%) and abnormal hepatic function (1.6%).<\/p>\n \nDosage interruptions of DATROWAY due to an adverse reaction occurred in 43% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (13%), stomatitis (7%), fatigue (6%), pneumonia (4%), anemia (2.4%), amylase increased (2.4%), keratitis (2.4%), ILD\/pneumonitis (1.6%), decreased appetite (1.6%), dyspnea (1.6%), rash (1.6%), and infusion-related reaction (1.6%).<\/p>\n \nDose reductions of DATROWAY due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (14%), keratitis (1.6%), fatigue (1.6%), decreased weight (1.6%) and COVID-19 (1.6%).<\/p>\n \nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were stomatitis (71%), nausea (50%), alopecia (49%), fatigue (42%), decreased hemoglobin (34%), decreased lymphocytes (32%), constipation (31%), increased calcium (31%), increased AST (28%), decreased white blood cell count (27%), increased lactate dehydrogenase (23%), musculoskeletal pain (22%), decreased appetite (20%), increased ALT (20%), and rash (20%).<\/p>\n \nClinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included dry skin, blurred vision, abdominal pain, conjunctivitis, dry mouth, ILD\/pneumonitis, skin hyperpigmentation, increased lacrimation, and visual impairment.<\/p>\n Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) \nSerious adverse reactions occurred in 17% of patients who received DATROWAY. Serious adverse reactions in >1% of patients who received DATROWAY were pneumonia (2.2%), vomiting (1.9%), COVID-19 (1.6%), and anemia (1.3%). Fatal adverse reactions occurred in one patient (0.3%) who received DATROWAY and was due to ILD\/pneumonitis.<\/p>\n \nPermanent discontinuation of DATROWAY due to an adverse reaction occurred in 4.7% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD\/pneumonitis (0.9%) and keratitis (0.9%).<\/p>\n \nDosage interruptions of DATROWAY due to an adverse reaction occurred in 35% of patients. Adverse reactions which required dosage interruption in >1% of patients included stomatitis (5%), increased amylase (4.1%), keratitis (3.4%), neutropenia (3.1%), COVID-19 (2.8%), pneumonia (2.2%), dry eye (1.9%), upper respiratory tract infection (1.6%), anemia (1.3%), leukopenia (1.3%), IRR (1.3%), and ILD\/pneumonitis (1.3%).<\/p>\n \nDose reductions of DATROWAY due to an adverse reaction occurred in 28% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (11%), keratitis (4.1%), fatigue (3.8%), increased amylase (2.8%), and pneumonia (1.3%).<\/p>\n \nThe most common (\u226520%) adverse reactions, including laboratory abnormalities in patients receiving DATROWAY, were stomatitis (63%), increased amylase (54%), nausea (48%), alopecia (43%), decreased hemoglobin (43%), decreased white blood cells (41%), constipation (40%), decreased calcium (39%), decreased lymphocytes (36%), fatigue (36%), decreased neutrophils (35%), increased ALT (28%), increased AST (27%), dry eye (26%), keratitis (26%), decreased albumin (25%), vomiting (23%), musculoskeletal pain (22%), decreased sodium (21%), and increased blood alkaline phosphatase (20%).<\/p>\n \nClinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions including anaphylactic reaction, diarrhea, conjunctivitis, lacrimation increased, dry mouth, dry skin, pruritus, rhinorrhea, blepharitis, meibomian gland dysfunction, blurred vision, ILD\/pneumonitis, visual impairment, photophobia, and madarosis.<\/p>\n Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer \nSerious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD\/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD\/pneumonitis.<\/p>\n \nPermanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD\/pneumonitis (1.7%) and fatigue (0.6%).<\/p>\n \nDosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD\/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%).<\/p>\n \nDose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%).<\/p>\n \nThe most common (\u226520%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%).<\/p>\n \nClinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD\/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis.<\/p>\n Use in Specific Populations<\/b><\/p>\n To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov\/medwatch<\/a>.<\/b><\/p>\n Please see <\/b>Prescribing Information<\/b><\/a> and <\/b>Medication Guide<\/b><\/a> for additional Important Safety Information.<\/b><\/p>\n Notes<\/span><\/b><\/p>\n Triple-negative breast cancer \nWhile some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.8<\/sup> Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.8<\/sup> For patients with metastatic disease with PD-L1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the 1st-line setting.13,14 <\/sup>However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, prior to the approval of DATROWAY, chemotherapy was the only approved 1st-line treatment.15<\/sup><\/p>\n \nTROP2 is a protein broadly expressed in several solid tumors, including TNBC.16<\/sup> TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.17,18<\/sup><\/p>\n TROPION-Breast02 \nThe dual primary endpoints of TROPION-Breast02 are progression-free survival (PFS) as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, ORR, duration of response, disease control rate, pharmacokinetics and safety.<\/p>\n \nTROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information, visit ClinicalTrials.gov<\/a>.<\/p>\n DATROWAY \nDATROWAY is also approved in more than 40 countries\/regions worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+\/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01<\/a> trial.<\/p>\n \nDATROWAYis available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR<\/i>-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR<\/i>-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05<\/a> and TROPION-Lung01<\/a> trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.<\/p>\n DATROWAY clinical development program Daiichi Sankyo collaboration AstraZeneca in breast cancer \nAstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumor environment.<\/p>\n \nWith fam-trastuzumab deruxtecan-nxki, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and expanding its potential in earlier lines of treatment and in new breast cancer settings.<\/p>\n \nIn HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines fulvestrant and goserelin and aims to reshape the HR-positive space with first-in-class AKT inhibitor, capivasertib, the TROP2-directed ADC, DATROWAY, and next-generation oral SERD and potential new medicine camizestrant.<\/p>\n \nPARP inhibitor olaparib is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA<\/i> mutation. AstraZeneca with Merck & Co., Inc., (known as MSD outside the US and Canada) continue to research olaparib in these settings. AstraZeneca is also exploring the potential of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA<\/i>-mutated, HR-positive, HER2-negative advanced breast cancer.<\/p>\n \nTo bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of DATROWAY alone and in combination with immunotherapy durvalumab.<\/p>\n AstraZeneca in oncology \nThe Company\u2019s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.<\/p>\n \nAstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.<\/p>\n AstraZeneca References<\/b><\/p>\n \nDisclosure: Dr. Traina provides consulting and advisory services to AstraZeneca (and Daiichi Sankyo).<\/p>\n \nUS-111948 View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260520169319\/en\/<\/a><\/span><\/p>\n Media Inquiries
\nMay 22, 2026 \u2014 AstraZeneca and Daiichi Sankyo\u2019sDATROWAY\u00ae <\/sup>(datopotamab deruxtecan-dlnk) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1\/PD-L1 inhibitor therapy.<\/p>\n
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<\/b>Indications
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<\/b>DATROWAY\u00ae<\/sup> is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:<\/p>\n\n
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<\/b>Interstitial Lung Disease\/Pneumonitis
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<\/b>DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis.<\/p>\n
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<\/span>In the pooled safety population of 484 patients with NSCLC from TROPION-Lung01, TROPION-Lung05, and TROPION-PanTumor01, ILD\/pneumonitis occurred in 7% of patients treated with DATROWAY, including 0.6% of patients with Grade 3 and 0.4% with Grade 4. There were 8 (1.7%) fatal cases. The median time to first onset for ILD was 1.4 months (range: 0.2 months to 9 months). Eleven patients (2.3%) had DATROWAY withheld and 20 patients (4.1%) permanently discontinued DATROWAY due to ILD\/pneumonitis. Systemic corticosteroids were required in 79% (26\/33) of patients with ILD\/pneumonitis. ILD\/pneumonitis resolved in 45% of patients.<\/p>\n
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<\/span>In the pooled safety population of 841 patients with breast cancer from TROPION-Breast01, TROPION-Breast02, TROPION-PanTumor01 and TROPION-PanTumor02, ILD\/pneumonitis occurred in 3.0% of patients treated with DATROWAY, including 0.4% of patients with Grade 3. There were two fatal cases (0.2%). The median time to first onset for ILD was 5.3 months (range: 1.1 months to 19.3 months) and with a median duration of 1.2 months (range: 0.3 months to 5.2 months). Eight patients (1.0%) had DATROWAY withheld and 10 patients (1.2%) permanently discontinued DATROWAY due to ILD\/pneumonitis. Systemic corticosteroids were required in 64% (16\/25) of patients with ILD\/pneumonitis. ILD\/pneumonitis resolved in 40% of patients.<\/p>\n
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<\/b>DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision.<\/p>\n
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<\/b>DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis.<\/p>\n
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<\/b>Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells.<\/p>\n
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<\/b>The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 1365 patients as a single agent at 6 mg\/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This included 137 patients with NSCLC in TROPION-Lung05, 297 patients with NSCLC in TROPION-Lung01, 360 patients with HR-positive, HER2-negative breast cancer in TROPION-Breast01, 319 patients with TNBC in TROPION-Breast02, 50 patients with NSCLC and 83 patients with breast cancer in TROPION-PanTumor01, and 40 patients with NSCLC and 79 patients with breast cancer in TROPION-PanTumor02. Among the 1365 patients who received DATROWAY, 48% were exposed for greater than 6 months and 22% were exposed for greater than one year. In this pooled safety population, the most common (\u226520%) adverse reactions were stomatitis (63%), nausea (51%), fatigue (42%), alopecia (38%), constipation (30%), vomiting (23%), decreased appetite (22%), and rash (20%). In this pooled safety population, the most common (\u22652%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes (8%), decreased hemoglobin (3.7%), decreased sodium (3.0%), and decreased blood potassium (2.3%).<\/p>\n
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<\/span>TROPION-Lung05, TROPION-Lung01, TROPION-PanTumor01
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<\/i>The safety of DATROWAY was evaluated in 125 patients with EGFR-mutated NSCLC who received DATROWAY 6 mg\/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity in TROPION-Lung05 and TROPION-Lung01 as well as TROPION-PanTumor01. Among these patients, the median duration of treatment was 6.1 months (range 0.7 months to 41.7 months).<\/p>\n
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<\/span>TROPION-Breast02
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<\/i>The safety of DATROWAY was evaluated in 319 patients with triple-negative breast cancer who received at least one dose of DATROWAY 6 mg\/kg in TROPION-Breast02. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 8.5 months (range: 0.7 months to 38.0 months) for patients who received DATROWAY.<\/p>\n
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<\/span>TROPION-Breast01
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<\/i>The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+\/ISH-) breast cancer who received at least one dose of DATROWAY 6 mg\/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY.<\/p>\n\n
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<\/b>TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.3,4<\/sup> In the US, an estimated 32,000 to 48,000 cases of TNBC were diagnosed in 2025, and approximately 11,000 patients with TNBC receive treatment in the 1st-line setting each year.5-7 <\/sup>TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.8-10 <\/sup>Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,11,12<\/sup><\/p>\n
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<\/b>TROPION-Breast02 is a global, multicenter, randomized, open-label Phase III trial evaluating the efficacy and safety of DATROWAY versus investigator\u2019s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.<\/p>\n
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<\/b>DATROWAY(datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the US only) is a TROP2-directed ADC. Designed using Daiichi Sankyo\u2019s proprietary DXd ADC Technology, DATROWAY is one of seven DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca\u2019s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.<\/p>\n
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<\/b>A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight Phase III trials in lung cancer, five Phase III trials in breast cancer, and one Phase III trial and one Phase II\/III trial in urothelial cancer evaluating DATROWAY as a monotherapy and in combination with other cancer treatments in various settings.<\/p>\n
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<\/b>AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize fam-trastuzumab deruxtecan-nxki in March 2019<\/a> and DATROWAY in July 2020<\/a>, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of fam-trastuzumab deruxtecan-nxki and DATROWAY.<\/p>\n
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<\/b>Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need \u2013 with the bold ambition to one day eliminate breast cancer as a cause of death.<\/p>\n
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<\/b>AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.<\/p>\n
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<\/b>AstraZeneca (LSE\/STO\/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca\u2019s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com<\/a> and follow the Company on social media @AstraZeneca<\/a>. The contents of AstraZeneca\u2019s website do not form part of this document and no one should rely on such websites or the contents thereof in reading this document.<\/p>\n\n
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Last Updated 05\/26<\/p>\n<\/p>\n
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Fiona Cookson
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+1 212 814 3923<\/p>\n
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