• Vk
  • LinkedIn
  • Youtube
X7 Research
  • News
  • Registration strategy and Сonsulting
    • Budgeting
    • Registration strategy development
    • Study feasibility
    • Vendor selection
    • Data search and analysis
  • Clinical trials
    • Outsourcing CRAs in Russia and the EAEU
    • Development of medical documentation and biostatistics
    • Monitoring
    • Data-management
    • Patient home visits
    • Bioequivalence study
    • Therapeutic equivalence studies
    • Clinical trials of medical devices
  • Registration
    • Audit of the registration dossier
    • Bringing the registration dossier in compliance with the requirements of the EAEU
    • Conversion of registration dossier into XML format
    • PIL readability user testing
    • Translation of the Registration dossier
    • Turnkey registration
  • Post-authorization clinical studies
    • Phase IV studies
    • Non-interventional studies
    • Investigator-initiated studies
    • Post-authorisation safety study
    • Marketing research
  • Pharmacovigilance
    • QPPV in the EAEU
    • Safety monitoring of medical devices
    • Building a pharmacovigilance system
    • Safety in clinical trials
    • Pharmacovigilance audit
    • Pharmacovigilance contact person
  • Therapeutic expertise
    • Clinical trials in Oncology in the EAEU
  • Contact
  • EnglishEnglish
  • Menu

A drug for the treatment of cancers was approved in the USA

26.12.2018/in News /by Evgeniy Makarevich

The FDA approved Vitrakvi (Loxo Oncology) in fast forward for the treatment of cancer in adults and children with a certain genetic mutation (biomarker). As noted by the FDA, this is a second drug approved for the treating of tumors regardless of their location.

Vitrakvi is intended for the treatment of adults and children with various neoplasms with mutations characterized by a fusion of the TRK gene and with the progressive disease after therapy. Such mutations are rare and located in many body parts.

The efficacy of the drug was studied in three clinical studies involving 55 patients with solid tumors and fusion of the TRK gene with metastases and those who didn’t have surgery, as well as patients with progressive disease after treatment.

According to the data obtained, the overall response rate was 75%. In 73% of patients, the response was maintained for at least six months, and in 39% – for one year or more. Among the tumors responded to the therapy are soft tissue sarcoma, salivary gland cancer, infantile fibrosarcoma, thyroid cancer, and lung cancer.

Side effects associated with taking Vitrakvi were: fatigue, nausea, cough, constipation, diarrhea, dizziness, vomiting, and increased levels of liver enzymes.

Link: www.labclinpharm.ru

Share this entry
  • Share on Twitter
  • Share on WhatsApp
  • Share on Pinterest
  • Share on LinkedIn
  • Share on Tumblr
  • Share on Vk
  • Share on Reddit
  • Share by Mail

YOU MAY ALSO BE INTERESTED IN

Publications
Readability User Testing of Package Information Leaflets (PIL) in EAEU
Read More
Publications
Remote clinical trial monitoring
Read More
Publications
Post-authorization studies of drug safety in Russia
Read More

RUBRICS

Registration strategy and Сonsulting

Clinical trials

Registration

Post-authorization clinical studies

Pharmacovigilance

LATEST PUBLICATIONS

  • Corrections to clinical trial documents due to COVID-19. Russian experience.
  • WHAT IS BIOEQUIVALENCE
  • THE VOLUME OF RUSSIAN PHARMACEUTICAL MARKET 2016-2019

Tags

bioequivalenceClinical trials in the CISfeasibilitymonitoringRadiopharmaceuticals

CONTACT

0 + 7 = ?

This contact form is deactivated because you refused to accept Google reCaptcha service which is necessary to validate any messages sent by the form.

PRIVACY

Use of this site constitutes your consent to our Privacy Policy.


SOCIAL RESPONSIBILITY

X7 Research’s primary responsibility is to help our clients in bringing medicines & products to the market efficiently and safely.

The Best CRO for Clinical Trials | Full-service Global CRO — X7 Research

The Best CRO in Pharma | Clinical Research Organisation — X7 Research

The Best Contract Research Organisation (CRO) | Trusted CRO — X7 Research

The Best Clinical Research Organisation (CRO): Full Service CRO | X7 Research

The Best CRO in Research | Trusted CRO for Your Trail — X7 Research

The Best Clinical Trial Company | Global Full-service CRO - X7 Research

The Best Pharma CROs: Clinical Trials for Drugs | X7 Research

The Best CROs Company: Clinical Trials with Global CRO — X7 Research

The Best Pre-clinical CRO: Safety Assessment With X7 Research

The Best Clinical Development | Trusted CRO for Your Product: X7 Research

The Best Biostatistical Consulting: Statistical Services | X7 Research

The Best Pharmacovigilance Consulting Services | CRO — X7 Research

Feasibility in Clinical Trials: What is a Feasibility in Clinical Trials?

Clinical Study Trials: What are Clinical Study Trials?

Category
Strategy and consulting
Clinical trials
Registration
Post-authorization clinical studies
Pharmacovigilance

Registration strategy and Сonsulting
Registration strategy development
Budgeting
Study feasibility
Vendor selection
Data search and analysis

Clinical trials
Development of medical documentation and biostatistics
Monitoring
Data management
Patient home visits
Bioequivalence study
Therapeutic equivalence studies

Registration
Audit of the registration dossier
Dossier eaeu
Conversion of registration dossier into xml format
Pil readability user testing
Turnkey registration

Post-authorization clinical studies
Phase iv studies
Non interventional studies
Investigator initiated studies
Post authorisation safety study
Marketing research

Pharmacovigilance
Building a pharmacovigilance system
Safety in clinical trials
Pharmacovigilance audit
Pharmacovigilance contact person

Blog
Contacts

© Copyright 2010-2023 - X7 Research. All rights reserved.
Defeated virus: will the flu become a second smallpox? Valenta Farm presents an innovative formulation of a benzodiazepine drug
Scroll to top