Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Accelerated Approval: Oncopeptides' Pepaxto Will Test New Expedited Withdrawal Process

Executive Summary

Company’s appeal of the US FDA’s formal request to voluntarily withdraw accelerated approval of the multiple myeloma agent is expected to follow the streamlined procedures created in last year’s omnibus legislation, which would preclude a second advisory committee review of melflufen’s fate.

You may also be interested in...



New Accelerated Approval Withdrawal Process More Streamlined, Marks Says

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto

Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.

Pepaxto Withdrawal Dispute: Oncopeptides Details Plans For New Studies

An observational single-arm study and a dose-optimization study are planned if the FDA does not withdraw accelerated approval of the multiple myeloma drug, Oncopeptides says. If an additional confirmatory trial is needed, company suggests two different approaches, one of which is almost a repeat of the OCEAN study, the results of which remain in dispute.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148683

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