Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Genentech Herceptin adds FISH test

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech's sBLA to add fluorescence in situ hybridization (FISH) testing to Herceptin (trastuzumab) labeling clears FDA Aug. 28. The approval also adds data showing that patients testing positive on FISH benefited from the HER-2 breast cancer treatment. "In a retrospective analysis, patients selected using FISH testing treated with Herceptin in addition to standard chemotherapy had a 30% decrease in the risk of death and a 56% decrease in the risk of disease progression compared to patients treated with chemotherapy alone," the company said. Labeling already listed immunohistochemistry (IHC) as a diagnostic method of detecting HER-2 positive patients. FDA's Oncologic Drugs Advisory Committee unanimously recommended inclusion of the PathVysion FISH assay in Herceptin labeling in December 2001. The sBLA was submitted in March 200

You may also be interested in...

Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Start-Up Spotlight: Iraq War Veteran Deploys ‘Bone Paint’ To Combat Traumatic Injuries

Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts