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

Spectrum Puts Its Eggs In One Basket: Folotyn, Beleodaq To Share Confirmatory Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

With Spectrum’s Beleodaq’s accelerated approval for peripheral T-cell lymphoma, FDA rolls Folotyn accelerated approval requirement into one post-marketing trial that will provide answers on both drugs – including which is better against standard of care.

You may also be interested in...



Accelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule

Under sponsor's current timetable, a single, two-part trial for pralatrexate and belinostat would not complete until 2030, resulting in respective delays of 21 and 16 years in confirming or refuting clinical benefit following accelerated approval. ODAC will discuss Acrotech’s delayed confirmatory trial program on 16 November.

Onxeo Plans Clinical Trials For Three Phase III Orphan Oncologics

The year-old pan-European biotech is targeting advanced liver cancer, severe mucositis and the rare cancer, peripheral T-cell lymphoma, for its first products in the orphan oncology niche.

CDER Builds Strong Foundation Of NMEs For 2014 As Approval Total Hits 20

Pharmaceutical Approvals Monthly takes stock of FDA’s performance at mid-year: CDER only needs to clear eight more novel agents to top 2013 in new molecular entity and novel biologic approvals, and priority and orphan drugs make up a higher portion of novel approvals than in recent years.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077505

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