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 need^6,7,8.

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.