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

Talon Marqibo’s Fate May Hang On Adjudication Of Trial Subjects

This article was originally published in The Pink Sheet Daily

Executive Summary

With Talon offering a single Phase II trial to support its NDA for Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia, everything may hinge on the disagreement between the sponsor and FDA over whether eight patients or 13 out of 65 experienced some type of complete response.

You may also be interested in...



Talon Marqibo’s Confirmatory Trial Plan May Need To Be Reworked

FDA advisory committee members express concern about the toxicity of Marqibo in the elderly patients expected to enroll in the Phase III confirmatory study for advanced acute lymphoblastic leukemia.

Talon’s Marqibo Gets Lukewarm Endorsement From ODAC

A split Oncologic Drugs Advisory Committee vote moves Talon Therapeutics’ Marqibo (vincristine sulfate liposomal injection) for relapsed Philadelphia chromosome negative acute lymphoblastic leukemia one step closer to accelerated approval.

Talon May Soon Have First Marqibo Approval In Its Grasp

Biotech formerly known as Hana Biosciences submits NDA for the nano-encapsulated vincristine for use as salvage in adults with Ph- ALL.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073900

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