Extended indication

Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2

Therapeutic value

No estimate possible yet

Registration phase

Registration application pending

Product

Active substance

Trastuzumab deruxtecan

Domain

Oncology

Reason of inclusion

Indication extension

Main indication

Breast cancer

Extended indication

Extension of indication to include treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or withing 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer must additionally have received or be ineligible for endocrine therapy.

Proprietary name

Enhertu

Manufacturer

AstraZeneca

Mechanism of action

Antibody-drug conjugate

Route of administration

Intravenous

Therapeutical formulation

Injection / infusion solution

Budgetting framework

Intermural (MSZ)

Additional comments
HER2-low population in this trial including tumors with IHC 1+ and IHC 2+/ISH- HER2 expression  Patients in study progressed on, and would no longer benefit from endocrine therapy and have been treated with 1 or 2 prior chemotherapy/ adjuvant in the metastatic setting.

Registration

Registration route

Centralised (EMA)

ATMP

No

Submission date

June 2022

Expected Registration

July 2023

Orphan drug

No

Registration phase

Registration application pending

Additional comments
Fabrikant verwacht indiening in de eerste helft van 2022 en registratie in de eerste helft van 2023.

Therapeutic value

Current treatment options

SoC chemotherapie

Therapeutic value

No estimate possible yet

Substantiation

De DESTINY-Breast04 studie loopt op dit moment nog.

Frequency of administration

1 times every 3 weeks

Dosage per administration

5,4mg/kg

References
DB-04 (NCT03734029). Modi et al. N Engl J Med 2022; 387:9-20.

Expected patient volume per year

Additional comments
Het is op dit moment nog niet mogelijk in te schatten hoeveel patiƫnten van deze nieuwe populatie er in aanmerking zullen komen.

Expected cost per patient per year

References
https://www.fiercepharma.com/special-report/1-enhertu
Additional comments
De verwachte prijs in de Verenigde Staten is: $13,300 per maand. De prijs in Nederland is nog niet bepaald.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension

Yes

Indication extensions

Treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens (NCT03248492). Treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2therapies (2L) (NCT03529110). Treatment of HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens (NCT03329690). Treatment of adult patients with HER2-mutated, Unresectable and/or Metastatic non-small cell lung cancer (NSCLC) (NCT03505710).

References
Fabrikant

Other information

There is currently no futher information available.