What is Enhertu? | Information & FAQ
Last updated: 15 March 2022
Article reviewed by Dr. Jan de Witt
What is Enhertu?
Enhertu (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate targeted therapy indicated for the treatment of people with:
- Unresectable or metastatic HER2-positive breast cancer who have received at least two prior therapies for their metastatic cancer.
- Locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
It is available in single-dose vial form each containing 100 mg of fam-trastuzumab deruxtecan-nxki.12
Enhertu (fam-trastuzumab deruxtecan-nxki) is a medication used for the treatment of adult patients with previously treated unresectable or metastatic HER2 positive breast cancer or with advanced HER2 positive gastric cancer.
How much does Enhertu cost?
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Is Enhertu a chemo drug?
Yes, Enhertu is a chemo drug. It is also a targeted immunotherapy medicine. Chemotherapy medicines prevent cancer cells from growing and spreading by destroying the cells or stopping them from dividing. Enhertu has been made by joining two different types of anti-cancer drugs together to make one drug called antibody-drug conjugate (ADC). 3
Is Enhertu an immunotherapy?
Yes, Enhertu is also a targeted immunotherapy medicine. Immunotherapy drugs utilize the body’s immune system to fight cancer cells by stimulating the natural defenses of the body’s immune system. 4
How is Enhertu administered?
The standard dosage for Enhertu is 5.4 mg/kg body weight once every 3 weeks (21-day cycle).
It is administered as an intravenous infusion over 90 minutes. If well tolerated, subsequent infusions can be administered over 30 minutes. Reduction in dose may be required based on symptoms and experienced side effects. Do not increase the Enhertu dose after a dose reduction is made.
Complete information about Enhertu (fam-trastuzumab deruxtecan-nxki) dosage and administration can be found in the official prescribing information listed in our references section.1
Does Enhertu cause hair loss?
The most common side effects ( ≥20% of patients) listed in the prescribing information include: 1
- Hair loss
- Decreased appetite
- Low (white and/or red) blood cell counts
- Low platelet counts
The serious adverse reactions listed in the prescribing information include:
Enhertu (fam-trastuzumab deruxtecan-nxki) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.
Who manufactures Enhertu?
Enhertu is manufactured by AstraZeneca and Daiichi Sankyo. AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company with its headquarters in Cambridge, England. Daiichi Sankyo Company, Limited is a global pharmaceutical company and the second-largest pharmaceutical company in Japan.5
When was Enhertu FDA approved?
Enhertu (fam-trastuzumab deruxtecan-nxki) was approved by:
- Food and Drug Administration (FDA), USA:
- PMDA, Japan on 25 March 2020 for the treatment of patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy (limit the use to patients who are refractory or intolerant to standard treatments).
On 20 December 2019 with an accelerated approval for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 1
On 15 January 2020 for patients with previously treated HER2-positive metastatic gastric cancer.
The FDA granted Enhertu with Breakthrough Therapy and Orphan Drug Designation for the treatment of patients with advanced HER2-positive gastric cancer, and it is now under Priority Review for this indication.
Enhertu also received Breakthrough Therapy Designation for the treatment of HER2-mutant metastatic non-small cell lung cancer. 5
- ِِEnhertu - Breastcancer.org
- Immunotherapy - Breastcancer.org
- Enhertu (fam-trastuzumab deruxtecan-nxki)- Thesocialmedwork.com