UNDERSTANDING THE RESULTS

How was ENHERTU studied?

ENHERTU was studied in a clinical trial of 101 adults who received a 5.4 mg/kg dose and:

Had HER2-mutant NSCLC that had spread to other parts of their body (metastatic) or could not be removed by surgery (unresectable)
Had their disease return after a prior treatment for lung cancer

The study included many types of adults, including those of different ages, races, genders, and smoking histories.

This study only evaluated ENHERTU. There was not a comparison of results to another treatment option for HER2-mutant or metastatic NSCLC.

In a clinical study, about 58% of people* treated with ENHERTU had their tumors shrink

Of the people who responded to ENHERTU:

About 56% of people achieved what is known as a partial response, meaning their tumor shrank by at least 30%^†
About 2% of people achieved what is known as a complete response, meaning their tumor could not be seen on imaging tests^‡

^*30 of 52 people treated with ENHERTU had their tumors shrink.

^†29 of 52 people achieved a partial response with ENHERTU.

^‡1 of 52 people achieved a complete response with ENHERTU.

Half of the people who responded to ENHERTU were still responding after nearly 9 months

This is called median duration of response.^§

^§A median is the middle number in a set of numbers. Median duration of response is the length of time half of the people in the trial continued to respond after the first response was seen.

ENHERTU was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. ENHERTU is still being studied to confirm these results.

HER2 mutations can occur in a range of people with NSCLC, and the cause of these mutations is unknown

The adults with HER2-mutant unresectable or metastatic NSCLC who responded to ENHERTU included those of different ages, genders, races, smoking histories, and prior treatments

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
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

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 are encouraged to report negative 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).

Download the Medication Guide.

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

IMPORTANT SAFETY INFORMATION

What is ENHERTU?

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

Non-small cell lung cancer (NSCLC) that has a certain mutation in the HER2 gene and cannot be removed by surgery or has spread to other parts of your body (metastatic), and who have received a prior treatment. Your healthcare provider will perform a test to make sure ENHERTU is right for you.
- ENHERTU was FDA approved for this use based on a clinical study 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.

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 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

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:

Non-small cell lung cancer (NSCLC) that has a certain mutation in the HER2 gene and cannot be removed by surgery or has spread to other parts of your body (metastatic), and who have received a prior treatment. Your healthcare provider will perform a test to make sure ENHERTU is right for you.
- ENHERTU was FDA approved for this use based on a clinical study 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.