ENHERTU is a prescription medicine used to treat adults who have solid tumors that are HER2-positive (IHC 3+) and that cannot be removed by surgery or have spread to other parts of your body (metastatic), and who have received a prior treatment and who have no other satisfactory treatment options. Your healthcare provider will perform a test to make sure ENHERTU is right for you.
ENHERTU was FDA approved for this use based on clinical studies that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.
It is not known if ENHERTU is safe and effective in children.
HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry.
What should I know about HER2 and HER2 positivity?
HER2 is a protein that tells cells to grow. When cells produce too much HER2, they can become cancerous.
Excessive amounts of HER2 can be found in many different tumors.
HER2 levels can be determined by a testing method called immunohistochemistry (IHC).
HER2 IHC scores range from IHC 0 to IHC 3+. The highest level of HER2 positivity is IHC 3+.
ENHERTU is approved to treat certain patients who have HER2-positive (HER2+) cancers with a HER2 IHC score of 3+. Your score helps your healthcare provider determine if you may be eligible for ENHERTU.
The highest level of HER2 positivity (IHC 3+) occurs in many different types of solid tumors,* including:
*A solid tumor is a mass of cancer cells that grows in organs, muscles, or bones.
The highest level of HER2 positivity (IHC 3+) also occurs in multiple other tumor types.
ENHERTU was studied in 3 clinical trials of many different types of metastatic solid tumors that had the highest level of HER2 positivity (IHC 3+)
These 3 clinical trials included 192 previously treated adults:
- 111 people with various types of metastatic tumors, including biliary tract, pancreatic, ovarian, cervical, endometrial, bladder, salivary gland, and other cancers
- 17 people with metastatic non-small cell lung cancer (mNSCLC)
- 64 people with metastatic colorectal cancer (mCRC)
These studies only evaluated ENHERTU. There were no comparisons of results to other treatment options. Individual results may vary. ENHERTU may not work for everyone.
In the 3 clinical trials,
About half of people treated with ENHERTU had their tumors shrink†
†This is called the overall response rate.
metastatic tumors,
(57 of 111 people)had their
tumors shrink†
- 2.7% (3 people) had a complete response‡
- 48.6% (54 people) had a partial response§
- Median duration of response: 19.4 (range: 1.3 to 27.9+) months||
(9 of 17 people)had their
tumors shrink†
- 5.9% (1 person) had a complete response‡
- 47.1% (8 people) had a partial response§
- Median duration of response: 6.9 (range: 4.0 to 11.7+) months||
(30 of 64 people)had their
tumors shrink†
- 0 people had a complete response‡
- 46.9% (30 people) had a partial response§
- Median duration of response: 5.5 (range: 1.3+ to 9.7+) months||
A median is the middle number in a set of numbers.
+ indicates that the response to treatment is ongoing.
‡Complete response means there are no signs of cancer on a follow-up scan.
§Partial response means the tumors shrank by at least 30%.
||Median duration of response is the length of time half of the people who responded to ENHERTU continued to respond after the first response was seen.
ENHERTU was FDA approved for this use based on clinical studies that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.
Explore clinical trial results in people with certain HER2+ (IHC 3+) metastatic cancers
What is the most important information I should know about ENHERTU?
ENHERTU can cause serious side effects
Some serious or life-threatening side effects may affect your lungs, heart, or white blood cell count, affecting your ability to fight infection.
Pay special attention to new or worsening symptoms as they may be related to:
Lung problems, like interstitial lung disease/pneumonitis, that may be severe, life-threatening, or that may lead to death
Lung problems, like interstitial lung disease/pneumonitis, that may be severe, life-threatening, or that may lead to death
Call or see your healthcare provider right away if you develop any of the following signs and symptoms
or if these symptoms get worse:
- Cough
- Trouble breathing or shortness of breath
- Fever
- Other new or worsening breathing symptoms (such as chest tightness, wheezing)
If lung problems develop, your healthcare provider may treat you with corticosteroid medicines.
Call or see your healthcare provider right away if you develop any of the following signs and symptoms or if these symptoms get worse:
- Cough
- Trouble breathing or shortness of breath
- Fever
- Other new or worsening breathing symptoms (such as chest tightness, wheezing)
If lung problems develop, your healthcare provider may treat you with corticosteroid medicines.
Low white blood cell count (neutropenia)
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
- 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
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 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
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
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
What are the most common side effects of 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
- Stomach-area pain
- 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
- Stomach-area pain
- The majority of side effects in people receiving ENHERTU were mild or moderate;¶ however, some people may have serious side effects that could lead to death. It is important to call your doctor for medical advice about side effects
¶Mild side effects are side effects you may have but they show no outward signs or medical intervention may not be needed. Moderate side effects may require some medical intervention or may affect you as you do day-to-day activities.
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 healthcare provider for medical advice about side effects. You are encouraged to report side effects of ENHERTU by calling 1-877-437-7763. If you prefer to report these to the FDA, visit www.FDA.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).
Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
If you are interested in sharing your story and experience with HER2+ (IHC 3+) metastatic tumors, please call 1-877-4DS-PROD (1-877-437-7763) or email DSAdvocacy@dsi.com to speak with a Daiichi Sankyo and/or AstraZeneca representative.
