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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

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 * 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.


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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