• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • NSCLC
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

FDA opens discussion on guidance for companion diagnostics

Article

FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use.

WASHINGTON-FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use. The draft document is intended to provide guidance on the agency's policy for reviewing a companion diagnostic and the corresponding drug therapy.

One common type of companion diagnostic determines whether a patient has a specific gene amplification or protein overexpression that could predict whether a drug might benefit the patient. For example, in 1998, FDA approved Herceptin (trastuzumab), a breast cancer drug designed to target HER2 gene amplification or HER2 protein overexpression. The drug was approved with a companion gene test.

Today, testing is routinely performed on women diagnosed with breast cancer to help healthcare professionals determine whether the patient would benefit from Herceptin.

ENTITIES MUST COLLABORATE

Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health, said in a release that it is the agency's goal "to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients."

The draft guidance also clarifies FDA's definition of a companion diagnostic and identifies instances where FDA may approve a targeted medicine when the potential benefits outweigh the risks of not having a cleared or approved companion diagnostic. The therapy could be approved first while the companion diagnostic may be approved or cleared later through the appropriate device submission process.

Related Videos
Video 3 - "In-Office Procedures, Over-the-Counter Options, Treatment Delays, and Costs"
Video 6 - "Safety Analysis and Interpreting Results from MAJIC-PV"
Video 5 - "Key Findings from MAJIC-PV"
Video 2 - "Traditional Treatment of Demodex Blepharitis, FDA approval, and Lotilaner Ophthalmic Solution, 0.25%"
Gabriela Hobbs, MD, an expert on polycythemia vera
Gabriela Hobbs, MD, and Timothy Mok, PharmD, BCPS, BCOP
Video 1 - "Demodex Blepharitis: Prevalence, Symptoms, Quality of Life Impact, and Diagnosis"
Video 2 - "The Role of Ruxolitinib in Managing Hydroxyurea Resistance or Intolerance"
Video 1 - "Prevalence and Impact of Hydroxyurea Intolerance or Resistance in Polycythemia Vera"
Related Content
© 2024 MJH Life Sciences

All rights reserved.