Scrip 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

Spectrum regains apaziquone from Allergan, to file US NDA on pooled data

This article was originally published in Scrip

Executive Summary

Spectrum Pharmaceuticals has reacquired the rights to apaziquone from Allergan, but the company's stock price likely rose higher on 31 January due to Spectrum's announcement that the US FDA will allow submission of a new drug application (NDA) based on statistically significant results in a pooled data analysis from two failed Phase III bladder cancer studies.

You may also be interested in...



Spectrum Failed To Heed FDA Advice On Apaziquone, And Is Paying The Price

FDA's original advice against NDA submission foreshadows advisory committee conclusion that substantial evidence of efficacy in bladder cancer not demonstrated by two negative trials and a post hoc pooled analysis.

Spectrum's Apaziquone Pooled Analysis Can't Make Up For Negative Studies

Faced with two unsuccessful pivotal trials, FDA advisory committee concludes substantial evidence of a treatment effect in non-muscle invasive bladder cancer has not been demonstrated.

Spectrum's Apaziquone: Can Two Failed Studies Lead To An Approval?

Spectrum says 6% reduction in bladder cancer recurrence is clinically meaningful even though studies failed their primary endpoint; FDA advisory committee also will weigh issues of data pooling and timing of drug administration.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1135866

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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