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<\/a><\/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> \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> \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 DATROWAY <\/i>means 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> \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 DATROWAY <\/i>to 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> \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> \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> \nThe safety profile of DATROWAY in TROPION-Breast02 was consistent with previous clinical trials of DATROWAY in breast cancer.<\/p> \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> \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> \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> \nINDICATION AND IMPORTANT SAFETY INFORMATION FOR DATROWAY\u00ae<\/sup> (datopotamab deruxtecan-dlnk)\n \nImportant Safety Information<\/b><\/p> \nWarnings and Precautions\n \nLocally Advanced or Metastatic NSCLC\n \nUnresectable or Metastatic Breast Cancer\n \nPatients were excluded from clinical studies for a history of ILD\/pneumonitis requiring treatment with steroids or for ongoing ILD\/pneumonitis.<\/p> \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> \nWithhold DATROWAY in patients with suspected ILD\/pneumonitis and permanently discontinue DATROWAY if ><\/span>Grade 2 ILD\/pneumonitis is confirmed.<\/p> \nOcular Adverse Reactions\n \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> \nPatients with clinically significant corneal disease were excluded from clinical studies.<\/p> \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> \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> \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> \nStomatitis\n \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> \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> \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> \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> \nEmbryo-Fetal Toxicity\n \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> \nAdverse Reactions\n \nLocally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer\n \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> \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> \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> \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> \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> \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> \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> \nUnresectable or Metastatic Triple-Negative Breast Cancer (TNBC)\n \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> \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> \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> \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> \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> \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> \nUnresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer\n \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> \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> \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> \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> \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> \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> \nUse in Specific Populations<\/b><\/p> \nMedia Inquiries<\/b> \nUS Media Mailbox: usmediateam@astrazeneca.com<\/a><\/p> 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-Br…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-10391","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/10391","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=10391"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/10391\/revisions"}],"predecessor-version":[{"id":10392,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/10391\/revisions\/10392"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=10391"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=10391"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=10391"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}\n
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