Vitrakvi was approved by the US Food and Drug Administration on November 26, 2018.
Vitrakvi is an oral tropomyosin receptor kinase inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase 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 treatment.
A tumor's underlying genomic profile is increasingly important in oncology treatment. NTRK gene fusions are genomic alterations that result in the overexpression of TRK fusion proteins.
Growing research suggests that the NTRK genes can become abnormally fused to other genes, producing a TRK fusion protein that can lead to the growth and survival of solid tumors in various sites of the body.
TRK fusion cancer occurs across a broad range of tumor types with varying frequency in both adult and pediatric patients.
Vitrakvi is designed to inhibit overexpressed TRK fusion proteins that lead to TRK fusion cancer growth and survival.
As a specialty pharmacy, US Bioservices has more than two decades of experience supporting small patient populations and patients with various types of cancers.
Through its Oncology Center of Excellence, US Bioservices' dedicated Oncology Patient Support Team will provide customised, high-touch services that address the unique clinical profile of this therapy and specific needs of the patient population.
US Bioservices' team of pharmacists and registered nurses provide therapy-specific education and 24/7 clinical support to patients and their caregivers.
Through the breadth of resources available at AmerisourceBergen, US Bioservices develops solutions to ensure all patients on therapy receive specialised support to navigate their treatment, clinically, economically and socially.
AmerisourceBergen companies supporting the launch of this therapy include ASD Healthcare for exclusive specialty distribution to hospitals, 340B eligible covered entities and any government entities; Oncology Supply for specialty distribution to physician practices; ION Solutions to support community oncology services and Lash Group for patient support services.
Vitrakvi is a limited distribution medication that is only available from select specialty pharmacies.
AVEO Oncology signs development and option agreement with HiberCell
Tabelecleucel's BLA transferred from Atara Biotherapeutics to Pierre Fabre Laboratories
UCB's KYGEVVI receives FDA approval for TK2d treatment
Camurus launches Oczyesa in Germany for patients with acromegaly
Servier's VORANIGO (vorasidenib) receives Prix Galien USA Award
Bavarian Nordic secures new EU contract for up to 8 million smallpox and mpox vaccine doses
GenSight Biologics secures FDA authorisation for expanded access to GS010/LUMEVOQ in the US
Ascletis Pharma Inc selects ASC36 as clinical development candidate
Zoetis announces EU approval for Portela to relieve osteoarthritis pain in cats
Samsung Bioepis to assume European commercialisation of BYOOVIZ (ranibizumab) from January 2026
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval