What is Vitrakvi (larotrectinib)?
Vitrakvi (larotrectinib) is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that1,2:
are caused by certain abnormal neurotrophic receptor tyrosine kinase (NTRK) gene1,
are metastatic or where surgical removal is likely to result in severe complications2, and
have no satisfactory alternative treatments or that have progressed following treatment2.
Who is Vitrakvi (larotrectinib) for?
Among all patients with solid tumors only those with an abnormal NTRK gene are eligible for treatment with Vitrakvi (larotrectinib). To determine whether a patient harbours this genetic mutation two techniques are commonly used: next generation sequencing (NGS) or fluorescence in situ hybridisation (FISH)2. NGS is a method used to resolve DNA sequence of an individual’s chromosome11, whereas FISH is a method to locate the position of DNA sequences on chromosomes12.
How does Vitrakvi (larotrectinib) work?
Vitrakvi (larotrectinib) is the first oral tyrosine kinase inhibitor approved for the treatment of tumors with NTRK gene fusion, regardless of its type and location3. NTRK gene fusions are chromosomal abnormalities that develop when an NTRK gene binds with another unrelated gene and forms mutated TRK proteins3. These TRK fusion proteins trigger uncontrolled formation and growth of cancerous cells in different parts of the body3. The active ingredient in Vitraki, larotrectinib, targets NTRK fusion genes that form mutated TRK proteins and inhibits survival of cancer cells10.
Where has Vitrakvi (larotrectinib) been approved?
Vitrakvi (larotrectinib) was approved by:
Food and Drug Administration (FDA), USA:
November 26, 20181 with an accelerated approval for the treatment of patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment4.
The FDA reviewed Vitrakvi (larotrectinib) under the Priority Review program, and granted it a breakthrough therapy designation and orphan drug designation5.
In March 2018, the European Medicines Agency granted larotrectinib orphan drug designation for the treatment of salivary gland cancer9.
Orphan drug, breakthrough therapy, and fast track designations are processes designed to facilitate and expedite the development of a medicine to treat serious conditions and fill an unmet medical need6,7,8.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Vitrakvi (larotrectinib) taken?
The standard dosage is2:
100 mg taken orally twice daily for patients with body surface area of at least 1.0 m2
100 mg/m2 for pediatric patients with body surface area less than 1.0 m2.
Reduction in dose may be required based on symptoms and experienced side effects. During treatment with Vizimpro (dacomitinib), interactions with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and sensitive CYP3A4 substrates should be avoided.
Complete information about Vitrakvi (larotrectinib) dosage and administration can be found in the official prescribing information listed in our resources section2
Note: Please consult with your treating doctor for personalised dosing, and interactions with other medicines.
Are there any known side effects or adverse reactions of Vitrakvi (larotrectinib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include2:
fatigue
nausea
dizziness
vomiting
increased aspartate aminotransferase (AST, an enzyme in amino acid metabolism)
cough
increased alanine transaminase (ALT, an enzyme in amino acid metabolism)
constipation
diarrhoea.
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include2:
pyrexia
diarrhoea
sepsis
abdominal pain
dehydration
vomiting
Use in specific populations
Vitrakvi (larotrectinib) can be fatal for a fetus, it is advised to avoid pregnancies and breastfeeding.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information2.
