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


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

Executive Summary

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.

You may also be interested in...

Talon’s Marqibo Faces Commercial Challenges After FDA Approval

Talon is preparing to launch the leukemia drug on its own in the first quarter of 2013 but remains in talks with potential strategic partners. The company agreed to monitor whether clinical practices experience safety or technical problems while following the 26-step process for preparing the drug for administration.

Marqibo Clears FDA Despite Advisory Committee Concerns About Confirmatory Trial

Talon’s liposomal vincristine receives accelerated approval for refractory Ph- acute lymphoblastic leukemia, with a requirement for a confirmatory trial. The firm has a first-line trial under way for that purpose, but it wasn’t well received by the Oncologic Drugs Advisory Committee.

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.

Related Content


Related Companies




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