Medullary thyroid cancer (MTC)

Active Ingredient: Vandetanib

Indication for Vandetanib

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old)

Vandetanib is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease.

Vandetanib is indicated in adults, children and adolescents aged 5 years and older.

For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.

For this indication, competent medicine agencies globally authorize below treatments:

100-200 mg once a day

Route of admnistration

Oral

Defined daily dose

100 - 200 mg

Dosage regimen

From 100 To 200 mg once every day

Detailed description

Dosing for paediatric patients should be on the basis of BSA in mg/m². Paediatric patients treated with vandetanib and patients' caregivers must be given the dosing guide and be informed on the correct dose to be taken with the initial prescription and each subsequent dose adjustment. Recommended dosing regimens and dose modifications are presented in the following table.

Dosing nomogram for Paediatric Patients with MTC:

BSA (m²)	Start dose (mg)^a	Dose increase (mg)^b when tolerated well after 8 weeks at starting dose	Dose reduction (mg)^c
0.7 - <0.9	100 every other day	100 daily	-
0.9 - <1.2	100 daily	7 day schedule: 100-200-100-200-100-200-100	100 every other day
1.2 - <1.6	7 day schedule: 100-200-100-200-100-200-100	200 daily	100 daily
≥1.6	200 daily	300 daily	7 day schedule: 100-200-100-200-100-200-100

^a The starting dose is the dose at which treatment should be initiated
^b Higher vandetanib doses than 150 mg/m² have not been used in clinical studies in paediatric patients
^c Patients with an adverse reaction requiring a dose reduction should stop taking vandetanib for at least a week. Dosing can be resumed at a reduced dose thereafter when fully recovered from adverse reactions

Dose adjustments in paediatric patients with MTC

In the event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1.
Patients who are on the starting dose (^a in table), should be recommenced at the reduced dose (^c in table).
Patients who are on the increased dose (^b in table), should be recommenced at the starting dose (a in table). If another event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose (^c in table) when toxicity has resolved or improved to CTCAE grade 1.
If a further event of CTCAE grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with vandetanib should be permanently stopped.

The patient must be monitored appropriately. Due to the 19-day half-life, adverse reactions including a prolonged QTc interval may not resolve quickly

Duration

Vandetanib may be administered until disease progression or until the benefits of treatment continuation do no longer outweigh its risk, thereby considering the severity of adverse events in relation to the degree of clinical stabilization of the tumour status.

Dosage considerations

It should be taken with or without food at about the same time each day.

Active ingredient

Vandetanib
Vandetanib is a potent inhibitor of vascular endothelial growth factor receptor-2 (VEGFR-2 also known as kinase insert domain containing receptor [KDR]), epidermal growth factor receptor (EGFR) and RET tyrosine kinases. Vandetanib is also a sub-micromolar inhibitor of vascular endothelial receptor-3 tyrosine kinase. Vandetanib inhibits VEGF-stimulated endothelial cell migration, proliferation, survival and new blood vessel formation in in vitro models of angiogenesis. In addition, vandetanib inhibits epidermal growth factor (EGF)-stimulated EGF receptor tyrosine kinase in tumour cells and endothelial cells. Read more about Vandetanib

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