Starting treatment with ENHERTU?
Learn more about ENHERTU,
including Important Safety Information
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)
- And had their disease return after a prior treatment for lung cancer
This study only evaluated ENHERTU. There was not a comparison of results to another treatment option for HER2-mutant unresectable or metastatic NSCLC.
In a clinical study, nearly 58% of people (30 of 52) 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†
*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; the length of time half of the people in the trial continued to respond after the first response was seen.
The median is the middle number when a group of numbers are arranged from lowest to highest.
How was ENHERTU studied?
ENHERTU was studied in many types of adults, including those with different:
- Ages
- Races
- Genders
- Smoking histories
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?”
ENHERTU is given as an intravenous (IV) infusion at a recommended dose of 5.4 mg/kg once every 3 weeks. There were more side effects, including serious lung problems, seen in patients with NSCLC who received a higher dose 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
- Muscle or bone pain
- Decreased appetite
- Low levels of blood potassium
- Diarrhea
- Cough
- Nausea
- Low white blood cell counts
- Low red blood cell counts
- Feeling tired
- Low platelet counts
- Increased liver function tests
- Vomiting
- Hair loss
- Constipation
- Muscle or bone pain
- Decreased appetite
- Low levels of blood potassium
- Diarrhea
- Cough
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).
