ENHERTU

What is 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.
• HER2-low breast cancer that cannot be removed by surgery or that has spread to other parts of your body (metastatic), and who have received a prior chemotherapy:
  • for metastatic disease, or
  • your disease has returned during or within 6 months of completing adjuvant chemotherapy (after surgery). Your healthcare provider will perform a test to make sure ENHERTU is right for you.
• 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

What are the ingredients in Enhertu?

Active Ingredient: fam-trastuzumab deruxtecan-nxki.

Inactive Ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, and sucrose

How does Enhertu work?

The active substance in Enhertu, trastuzumab deruxtecan, is made up of two active components which are linked together: Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to attach to HER2, which is found in large quantities on some cancer cells.

Interactions

Some medications interact with Enhertu, so it is important to tell your doctor about any medicines that you are currently taking, or if you start or stop any medicine while you are having cancer treatment. Also tell your doctor about any over-the-counter medicines, vitamins, minerals or herbal products that you take.

side effects ENHERTU

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 counts (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:

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.
• Females who are able to become pregnant should use effective birth control (contraception) during treatment and for at least 7 months after the last dose.
• Males with female partners who can become pregnant should use effective birth control (contraception) during treatment with ENHERTU and for at least 4 months after the last dose.

Before you receive , 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 passes into your breast milk. Do not breastfeed during treatment 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.

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.

How will I receive ENHERTU?

• You will receive ENHERTU into your vein through an intravenous (IV) line by your healthcare provider.
•  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?

can cause serious side effects. See “What is the most important information I should know about ENHERTU?”

 

The most common side effects , when used in people with metastatic breast cancer and HER2-mutant solid tumors include:

The most common side effects , when used in people with HER2-positive gastric or GEJ adenocarcinoma, include:

Clinical trials

HER2+ Breast Cancer

Food and Drug Administration (FDA), USA, Approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of non-resectable or metastatic HER2+ breast cancer was based on data from the DESTINY-Breast01 study (NCT03248492)

DESTINY-Breast01 was a multicenter, international, single-arm phase 2 study involving 184 patients with HER2+, non-resectable and/or metastatic breast cancer who had received two or more previous anti-HER2 therapies. Patients receiving Enhertu at a dose of 5.4 mg/kg intravenously every 3 weeks.

consequences
The two main efficacy outcomes were the overall response rate (ORR), defined as the proportion of patients who had a partial or complete response to treatment, and the duration of response (DOR), which is the time between the initial response to treatment and subsequent disease progression or relapse.

The majority of people in the study, 60.3%, saw their tumors shrink with Enhertu’s number

Some people achieved a complete response of 4.3%
56.0% of people achieved a partial response
97% of people treated with Enhertu had their tumors shrunk, stopped growing, or their tumor growth slowed.

In half of the people who responded to Enhertu, this response lasted an average of 14.8 months.

 

HER2+ stomach cancer

FDA approval of Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of HER2+ advanced gastric (stomach) cancer was based on results from the Fate-Gastric01 trial (NCT03329690).

DESTINY-Gastric01 was an open-label, randomized, phase 2 trial, which examined trastuzumab deruxtecan in comparison to chemotherapy in patients with HER2+ advanced gastric cancer. The study included 187 patients who received trastuzumab deruxtecan 6.4 mg/kg body weight every 3 weeks.

consequences
The main efficacy outcome was the overall response rate (ORR), which is defined as the proportion of patients who had a partial or complete response to treatment. The secondary outcome was overall survival.

In this study, Enhertu helped people live longer from chemotherapy. Tumors shrank in a greater number of people treated with Enhertu than with chemotherapy.

The majority of people in the study, 40.5% of people saw a response with Enhertu and 11.3% did with chemotherapy:

7.9% of people receiving Enhertu achieved a complete response versus no one receiving chemotherapy.
32.5% of people receiving Enhertu achieved a partial response, compared to 11.3% of those receiving chemotherapy.
84% of people receiving Enhertu had their tumors shrink, stop growing, or their tumor growth slowed, and 61% of people saw this while receiving chemotherapy.

Half of the study participants who responded were alive at 12.5 months. Of people taking chemotherapy, half were alive at 8.4 months of age. This was about 4 months longer with

Storage

 

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze.

Store in the original carton to protect from light until the time of reconstitution.

Do not shake the reconstituted or diluted solution.

 

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White to slightly yellow, elongated tablets of approximately 15.1 mm in length and 6.0 mm in width, with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.