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 Evolution Of Prostate Cancer Therapy Shaped Xtandi Review

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Medivation/Astellas’ enzalutamide capped off an extraordinary three-year run in advanced castration-resistant prostate cancer therapy, with three successive NMEs each offering a greater survival advantage than the last. That accelerated evolution of new therapies created a complex context for FDA reviews.

You may also be interested in...



Does Imlygic Make The Case For FDA Oncology Center Of Excellence?

Products like Amgen's viral therapy for melanoma could benefit under proposals to replace FDA's modality-based organization with disease-specific centers. FDA's biologics center proved itself capable of reviewing the oncologic, but the drugs center already had extensive recent experience with the fast-changing melanoma market.

Medivation/Astellas Will Be Ready For Xtandi To Enter Pre-Chemo Prostate Cancer Setting

The oncology drug has been submitted for approval in the larger chemotherapy-naïve patient population and Medivation intends to increase its sales force to support the launch.

Deals Of The Week: Exit From Ambit Tie-Up Just A Blip In Astellas’ Oncology Aspirations

DOTW looks at Astellas’ oncology ambitions plus its recent split with partner Ambit, as well as analysis of Shire’s buyout of Premacure, AbbVie’s out-license of an anti-interleukin-13 antibody to Receptos and the Merck/Luminex collaboration on a companion diagnostic for Alzheimer’s disease.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS004905

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