FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use.
WASHINGTON-FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use.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The draft guidance also clarifies FDA's definition of a companion diagnostic and identifies instances where FDA may approve a targeted medicine when the potential benefits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.
Unrealistic Portrayals of Cardiac Arrest in Contemporary Film | ACC 2025
March 31st 2025Cardiac arrests in contemporary film are largely inaccurate when it comes to survival rate and etiology, according to a poster presented today at the American College of Cardiology conference held March 29 to 31 in Chicago.
Read More
Breaking Down Health Plans, HSAs, AI With Paul Fronstin of EBRI
November 19th 2024Featured in this latest episode of Tuning In to the C-Suite podcast is Paul Fronstin, director of health benefits research at EBRI, who shed light on the evolving landscape of health benefits with editors of Managed Healthcare Executive.
Listen
In this latest episode of Tuning In to the C-Suite podcast, Briana Contreras, an editor with MHE had the pleasure of meeting Loren McCaghy, director of consulting, health and consumer engagement and product insight at Accenture, to discuss the organization's latest report on U.S. consumers switching healthcare providers and insurance payers.
Listen
Winrevair Reduced Risk of Morbidity and Mortality by 76% in PAH | ACC 2025
March 31st 2025In the ZENITH trial, Winrevair was evaluated based on a composite endpoint of all-cause death, lung transplantation or disease-related hospitalization for patients with pulmonary arterial hypertension.
Read More
Clopidogrel Beat Aspirin in Preventing Heart Attacks After PCI | ACC 2025
March 31st 2025Clopidogrel monotherapy may be an alternative to aspirin for prevention of cardiac events in high-risk patients after percutaneous coronary intervention, according to a new study presented at ACC 2025.
Read More