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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, half of the people taking ENHERTU were alive at 12.5 months. For people taking chemotherapy, half of the people were alive at 8.4 months. This was about 4 months longer with ENHERTU.

In the same clinical study, tumors shrank in more people treated with ENHERTU than with chemotherapy*:

  • 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 chemotherapy||

What is ENHERTU?

ENHERTU (en-HER-too) is a prescription medicine used to treat adults who have:

  • Stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2-positive and 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.

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.

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

63 of 125 people taking ENHERTU were still alive after 12.5 months vs 23 out of 62 people taking chemotherapy.

The number of people who had their tumors shrink is called the objective response rate (or ORR). ORR was achieved by 51 out of 126 people with ENHERTU compared to 7 out of 62 people with chemotherapy.

§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, 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%.

What is ENHERTU?

ENHERTU is a prescription medicine used to treat adults who have:

  • Stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2 positive and 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.

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 (such as 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 in people with HER2-positive gastric or GEJ adenocarcinoma, 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 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:

  • Stomach cancer called gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2 positive and 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.

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