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

Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals

Executive Summary

Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.

You may also be interested in...



Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors

Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.

Acadia's Nuplazid Hits A Review Roadblock, But Not A CRL (For Now)

Deficiencies identified by the US FDA could delay the approval of pimavanserin for hallucinations associated with dementia-related psychosis, but Acadia did not have details for investors.

US FDA ‘Project Post COVIDity’ Will Track Infection Impact On Cancer Patients Using Real-World Data

Oncology Center of Excellence program will use the Evidence Accelerator to examine COVID’s impact on treatment initiation, regimen selection and therapeutic utilization, potential adverse sequalae, and outcomes.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143834

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