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This site is intended for US residents 18 years of age or older. * Select A Cancer Type * HER2+ Metastatic Breast Cancer * HER2-Low Metastatic Breast Cancer * HER2-Mutant Metastatic Lung Cancer * HER2+ Advanced Stomach Cancer * Important Safety Information * Prescribing Information * Medication Guide * Healthcare Professional Site * Treatment Access * Home * HER2+ mBC & ENHERTU * Results With ENHERTU * Potential Side Effects * Support & Resources * Sign Up for Information MENU CLOSE * Home * HER2+ mBC & ENHERTU * Results With ENHERTU * Potential Side Effects * Support & Resources * Sign Up for Information * Select A Cancer Type * HER2+ Metastatic Breast Cancer * HER2-Low Metastatic Breast Cancer * HER2-Mutant Metastatic Lung Cancer * HER2+ Advanced Stomach Cancer * Important Safety Information * Prescribing Information * Medication Guide Healthcare Professional Site Treatment Access This site is intended for US residents 18 years of age or older. UNDERSTANDING THE RESULTS WHAT IS ENHERTU? ENHERTU is a prescription medicine used to treat adults who have human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment for metastatic disease, or have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer. HOW WAS ENHERTU STUDIED IN HER2+ MBC? ENHERTU was studied in many types of adults, including those with different: * Ages * Hormone receptor (HR) status * Tumors that had spread (metastasized) to other parts of the body, including the liver, lungs, and bone * Tumors that had spread to the brain and were stable ENHERTU was compared with Kadcyla® (ado-trastuzumab emtansine) in a clinical trial of 524 people who: * Had HER2+ breast cancer that had spread to other parts of their body or could not be removed by surgery, and * Had received a prior treatment for HER2+ metastatic breast cancer or had cancer come back during or within 6 months of treatment after surgery In this trial, 261 people were treated with ENHERTU and 263 were treated with Kadcyla. WHAT WERE THE RESULTS OF THE ENHERTU STUDY? Progression-free survival Initial results (May 2021) With ENHERTU, people lived longer without their cancer progressing compared to Kadcyla * People were 72% more likely to live longer without their cancer progressing compared to Kadcyla * In the first assessment, 174 (66.6%) of 261 people treated with ENHERTU lived without their cancer progressing at the time of the first assessment compared to 105 (39.9%) of 263 people treated with Kadcyla; median progression-free survival (mPFS) was not reached with ENHERTU, and mPFS for people taking Kadcyla was about 7 months Updated results (July 2022) Median progression-free survival with ENHERTU and Kadcyla*†‡§ with ENHERTU and with Kadcyla *A median is the middle number in a set of numbers. †Median progression-free survival is the length of time from the start of treatment that half of the people in the trial had gone without disease progression or dying. ‡The updated assessment was not tested for statistical significance and not designed to show differences between treatments. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone. §Based on the updated assessment: 144 (55.1%) of 261 people treated with ENHERTU lived without their cancer progressing at the time of the updated assessment compared to 92 (34.9%) of 263 people treated with Kadcyla. Overall survival Initial results (May 2021) * In the first assessment, overall survival results were not available Updated results (July 2022) People taking ENHERTU lived longer compared with people taking Kadcyla * At the time of the updated assessment, more than 50% of people receiving ENHERTU or Kadcyla were still alive∥ * ENHERTU reduced the risk of death in patients by 36% vs Kadcyla Overall survival rates with ENHERTU and Kadcyla¶# of people were alive at 24 months with ENHERTU and of people were alive at 24 months with Kadcyla * 170 (65.1%) of 261 people treated with ENHERTU were alive at 24 months, and 138 (52.4%) of 263 people were alive with Kadcyla ∥At the time of the updated assessment, since more than 50% of people receiving ENHERTU or Kadcyla were still alive, the results could not be reported in months. ¶Overall survival rate is the percentage of people who are still alive at a certain time point after either the date of diagnosis or the start of treatment. #Not tested for statistical significance and not designed to show differences between treatments. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone. Response to treatment Initial results (May 2021) In the first assessment, 83% of people had their tumors shrink with ENHERTU and 36% with Kadcyla**††‡‡ **This is called the overall response rate. * 16% (39 of 248 people) achieved a complete response with ENHERTU and 8% (20 of 241 people) with Kadcyla. A complete response means the tumor could not be seen on imaging tests * 67% (166 of 248 people) achieved a partial response with ENHERTU and 28% (67 of 241 people) with Kadcyla. A partial response means the tumor shrank by at least 30% * 15% (37 of 248 people) achieved stable disease with ENHERTU and 40% (97 of 241 people) with Kadcyla. This means that people did not have their tumor increase in size by more than 20% or decrease in size by more than 30% Updated results (July 2022) Overall response rates with ENHERTU and Kadcyla††§§ of people had their tumors shrink with ENHERTU and of people had their tumors shrink with Kadcyla Of the people who responded to ENHERTU in the updated assessment: * 21% (52 of 246 people) achieved a complete response with ENHERTU and 9% (21 of 240 people) treated with Kadcyla * 61% (150 of 246 people) achieved a partial response with ENHERTU and 28% (67 of 240 people) treated with Kadcyla * 15% (38 of 246 people) achieved stable disease with ENHERTU and 40% (96 of 240 people) treated with Kadcyla ††Not statistically significant. Statistical significance describes a mathematical measure of difference between groups. The difference is statistically significant if it is greater than what might be expected to happen by chance alone. ‡‡Based on the people in the first assessment with measurable disease (248 people who received ENHERTU and 241 people who received Kadcyla). In the first assessment, 205 (82.7%) of 248 people had their tumors shrink with ENHERTU and 87 (36.1%) of 241 people with Kadcyla. §§Based on the people in the updated assessment with measurable disease (246 people who received ENHERTU and 240 people who received Kadcyla); 202 (82.1%) of 246 people had their tumors shrink with ENHERTU and 88 (36.7%) of 240 people with Kadcyla. Disease control Initial results (May 2021) * In the first assessment, 98% (242 of 248 people) treated with ENHERTU had their tumors either shrink, stop growing, or slow down Updated results (July 2022) 98% of people treated with ENHERTU had their tumors respond to treatment in at least one of the following ways∥∥¶¶: Shrink Stop growing Slow down ∥∥This is called the disease control rate.## A VARIETY OF PATIENTS WITH HER2+ MBC RESPONDED TO ENHERTU. ¶¶In the updated assessment, 240 (97.6%) of 246 people treated with ENHERTU achieved disease control: 21.1% complete response (52 people) + 61.0% partial response (150 people) + 15.4% stable disease (38 people). ##The disease control rate is the percentage of people who have achieved complete response, partial response, or stable disease. Would you like to receive updates about ENHERTU? SIGN UP FOR INFORMATION HER2, human epidermal growth factor 2; HR, hormone receptor; mBC, metastatic breast cancer. Not an actual patient. IMPORTANT SAFETY INFORMATION What is ENHERTU? ENHERTU is a prescription medicine used to treat adults who have: * Human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment: * for metastatic disease, or * have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer. It is not known if ENHERTU is safe and effective in children. What is the most important information I should know about ENHERTU? ENHERTU can cause serious side effects, including: Lung problems that may be severe, life-threatening or that may lead to death. If you develop lung problems your healthcare provider may treat you with corticosteroid medicines. Tell your healthcare provider right away if you get any of the following signs and symptoms: * Cough * Trouble breathing or shortness of breath * Fever * Other new or worsening breathing symptoms (e.g., chest tightness, wheezing) Low white blood cell count (neutropenia). Low white blood cell counts are common with ENHERTU and can sometimes be severe. Your healthcare provider will check your white blood cell counts before starting ENHERTU and before starting each dose. Tell your healthcare provider right away if you develop any signs or symptoms of an infection or have fever or chills during treatment with ENHERTU. Heart problems that may affect your heart’s ability to pump blood. Your healthcare provider will check your heart function before starting treatment with ENHERTU. Tell your healthcare provider right away if you get any of the following signs and symptoms: * New or worsening shortness of breath * Coughing * Feeling tired * Swelling of your ankles or legs * Irregular heartbeat * Sudden weight gain * Dizziness or feeling light-headed * Loss of consciousness Your healthcare provider will check you for these side effects during your treatment with ENHERTU. Your healthcare provider may reduce your dose, delay treatment or completely stop treatment with ENHERTU if you have severe side effects. Harm to your unborn baby. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ENHERTU. * If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with ENHERTU. * Females who are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for 7 months after the last dose. * Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for 4 months after the last dose. Before you receive ENHERTU, tell your healthcare provider about all of your medical conditions, including if you: * Have lung or breathing problems. * Have signs or symptoms of an infection. * Have or have had any heart problems. * Are breastfeeding or plan to breastfeed. It is not known if ENHERTU passes into your breast milk. Do not breastfeed during treatment with ENHERTU and for 7 months after the last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive ENHERTU? * You will receive ENHERTU into your vein through an intravenous (IV) line by your healthcare provider. * ENHERTU is given 1 time every three weeks (21-day treatment cycle). * Your healthcare provider will decide how many treatments you need. * Your healthcare provider will give you medicines before your infusion to help prevent nausea and vomiting. * Your healthcare provider may slow down or temporarily stop your infusion of ENHERTU if you have an infusion-related reaction, or permanently stop ENHERTU if you have severe infusion reactions. * If you miss a planned dose of ENHERTU, call your healthcare provider right away to schedule an appointment. Do not wait until the next planned treatment cycle. What are the possible side effects of ENHERTU? ENHERTU can cause serious side effects. See “What is the most important information I should know about ENHERTU?” The most common side effects of ENHERTU when used at the 5.4 mg/kg dose include: * Nausea * Low white blood cell counts * Low red blood cell counts * Feeling tired * Low platelet counts * Increased liver function tests * Vomiting * Hair Loss * Constipation * Decreased appetite * Low levels of blood potassium * Diarrhea * Muscle or bone pain ENHERTU may cause fertility problems in males, which may affect the ability to father children. Talk to your healthcare provider if you have concerns about fertility. These are not all of the possible side effects of ENHERTU. Call your doctor for medical advice about side effects. You may report side effects to Daiichi Sankyo at 1-877-437-7763 or to FDA at 1-800-FDA-1088. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide. What is ENHERTU? ENHERTU is a prescription medicine used to treat adults who have: * Human epidermal growth factor receptor 2 (HER2)-positive breast cancer that cannot be removed by surgery or that has spread to other parts of the body (metastatic), and who have received a prior anti-HER2 breast cancer treatment: * for metastatic disease, or * have breast cancer that has come back during or within 6 months of completing treatment for their early-stage breast cancer. It is not known if ENHERTU is safe and effective in children. * PRESCRIBING INFORMATION * TERMS AND CONDITIONS * CONTACT US * IMPORTANT SAFETY INFORMATION * PRIVACY POLICY * ABOUT DAIICHI SANKYO * SITE MAP * PRESCRIBING INFORMATION * IMPORTANT SAFETY INFORMATION * TERMS AND CONDITIONS * PRIVACY POLICY * CONTACT US * ABOUT DAIICHI SANKYO * SITE MAP To contact us with questions or concerns about a Daiichi Sankyo product, please call us: 1-877-4DS-PROD (1-877-437-7763). ENHERTU® is a registered trademark of Daiichi Sankyo Company, Limited. Other brands listed are the trademarks of their respective owners and are not trademarks or registered trademarks of Daiichi Sankyo or AstraZeneca. © 2024 Daiichi Sankyo, Inc. and AstraZeneca. PP-US-ENB-3022 02/24