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

UsernamePublicRestriction
UsernamePublicRestriction

Genasense panel questioned

Executive Summary

In a Sept. 26 letter to Oncology Office Director Richard Pazdur, Emil Freireich (M.D. Anderson) expresses concern that FDA's Oncologic Drugs Advisory Committee "was comprised of specialists who frankly admitted having no experience" with chronic lymphocytic leukemia for the panel's review of Genta's Genasense; the panel recommended against approval of oblimersen Sept. 6 (1"The Pink Sheet" Sept. 11, 2006, p. 3). Genasense's positive impacted on a composite response endpoint in pivotal trials merits approval, Freireich states...

You may also be interested in...



Genasense Accelerated Approval Not Supported Due To Failed Outcomes Data

Accelerated approval based on response rate is not appropriate for Genta's Genasense given the Bcl-2 inhibitor's failure to show a benefit on clinical outcomes in a randomized Phase III trial, FDA and members of its Oncologic Drugs Advisory Committee said during a Sept. 6 meeting

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 

UsernamePublicRestriction

Register

OM004674

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

Cancel