About ENHERTU

About ENHERTU

Understanding HER2+ advanced stomach cancer

What is HER2?
HER2 is a protein that
tells cells to grow. In HER2+
stomach cancer, the cancer
cells have too much HER2,
which leads to
cancer growth

These cells grow and
divide faster than
healthy cells, causing
tumors to form

In advanced stomach
cancer, the cancer has
started to spread to areas
near the stomach or to other
parts of the body

Understanding ENHERTU

Understanding
ENHERTU

What is ENHERTU?

ENHERTU® (fam-trastuzumab deruxtecan-nxki) is a prescription medicine used in adults:

  • To treat HER2+ stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that has spread to areas near your stomach (locally advanced) or that has spread to other parts of your body (metastatic), and
  • Who have received a prior trastuzumab-based regimen

It is not known if ENHERTU is safe and effective in children.

How was ENHERTU studied?

ENHERTU was studied in comparison with the doctor's choice between 2 commonly used chemotherapies (irinotecan or paclitaxel) in 188 people with HER2+ advanced stomach cancer.

How is ENHERTU thought to work?

ENHERTU is made
up of an antibody
with a chemotherapy
attached
The ENHERTU
antibody targets and
attaches to the HER2+
cancer cell
ENHERTU enters
the cancer cell and
the chemotherapy
is released
The ENHERTU
chemotherapy
helps destroy the
cancer cell

Although ENHERTU is designed to target HER2+ cancer cells, it may affect healthy cells.
ENHERTU may not work for everyone.

How will I receive my ENHERTU treatment?

ENHERTU is taken alone without the need for other cancer medicines to treat advanced stomach cancer

weeks-desk weeks-mob
ENHERTU is given as an intravenous (IV) infusion once every 3 weeks.

How long do the infusions take?

Your healthcare provider will decide how many treatments you need.

Your healthcare provider will decide how many treatments you need.

Your healthcare provider may obtain a new tumor sample before starting ENHERTU

Your healthcare provider may adjust your dose if you have side effects
with ENHERTU

  • Your healthcare provider may slow down or temporarily stop your infusion of ENHERTU if you have an
    infusion-related reaction
  • Your healthcare provider may permanently stop ENHERTU if you have certain side effects
  • 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

ENHERTU clinical study

In a clinical study of 188 people with previously treated HER2+ advanced stomach cancer,

ENHERTU helped people live longer than with chemotherapy*

Among people in the trial...

*Chemotherapy used in the clinical study was the doctor’s choice between 2 commonly used chemotherapies (irinotecan or paclitaxel).

63 of 126 people taking ENHERTU were still alive after 12.5 months vs 23 out of 62 people taking chemotherapy.

In the same clinical study,

Tumors shrank in more people treated with ENHERTU than
with chemotherapy*‡

ENHERTU
enhertuImg
Chemotherapy
ChemotherapyImg
  • 40.5% (51 of 126) of people saw a confirmed response with ENHERTU and 11.3% (7 of 62) did with chemotherapy‡§
  • 7.9% (10 of 126) of people taking ENHERTU achieved a complete response, meaning their tumor could not be seen on imaging tests. This does not always mean the cancer has been cured. No one taking chemotherapy (0 of 62) had a complete response
  • 32.5% (41 of 126) of people taking ENHERTU achieved a partial response, which means the tumor shrank by at least 30%. 11.3% (7 of 62) of those taking chemotherapy had a partial response
  • 84% (106 of 126) of people taking ENHERTU saw their tumors shrink, stop growing, or the growth of their tumors slowed, and 61% (38 of 62) of people saw this while receiving chemotherapyll

The amount of people who had their tumors shrink is called the objective response rate (or ORR).

§The response was observed by the treating doctor and then agreed upon by a review panel. A second scan 4 or more weeks after the first was used to confirm
the results.

||The 84% shown is the disease control rate of the clinical study, which is the sum of the ORR and stable disease rate. Stable disease means that the tumor did not increase in size by more than 20% nor decrease in size by more than 30%.

Some people may have side effects when taking 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 in people with stomach cancer, include:

  • Low red blood cell counts
  • Low white blood cell counts
  • Low platelet counts
  • Nausea
  • Decreased appetite
  • Increased liver function tests
  • Feeling tired
  • Diarrhea
  • Low levels of blood potassium
  • Vomiting
  • Constipation
  • Fever
  • Hair loss

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 FDA at 1-800-FDA-1088.

Please click here for full Prescribing Information, including Boxed WARNINGS, and click here for
Medication Guide
.

Downloadable Resources for Patients and Caregivers

Understanding and managing
side effects during treatment
with ENHERTU

 

Starting treatment with ENHERTU?
Learn more about ENHERTU, including
Important Safety Information