On November 28, 2018 US Bioservices, a specialty pharmacy that is a part of AmerisourceBergen, reported that it has been selected by Bayer and its collaboration partner Loxo Oncology, Inc. to dispense Vitrakvi (larotrectinib). Vitrakvi was approved by the U.S. Food and Drug Administration (FDA) on November 26, 2018 (Press release, US Bioservices, NOV 28, 2018, View Source [SID1234531686]). Vitrakvi is an oral tropomyosin receptor kinase (TRK) inhibitor for the treatment of adult and pediatric 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 treatment.
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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.
"We’re proud to be among a very select group of pharmacies providing patients access to this important therapy," said Randy Maloziec, Vice President of BioPharma Relations at US Bioservices. "Advancements in oncology are helping many patients, and with Vitrakvi’s ability to inhibit a specific oncogenic driver irrespective of tumor location, this innovative therapy has the potential to support a diverse set of cancer patients. US Bioservices is committed to staying at the forefront of specialized support that helps patients realize the greatest benefit from new, advanced therapies."
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 customized, 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 specialized 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. Physicians may submit prescriptions to US Bioservices via phone (833-230-1407), fax (833-878-5917), ePrescribe or the MyPathpoint Prescriber Portal.