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

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

Executive Summary

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.

You may also be interested in...



Patient Voices Swayed FDA's Imlygic Review Team

Testimony from patients about the cosmetic and psychological advantages of seeing melanoma lesions shrink was a key element in agency's decision to offer full approval to Amgen's talimogene laherparepvec despite serious concerns about the clinical meaning of the pivotal trial's durable response rate endpoint.

FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure

Friends of Cancer Research proposes realignment of medical product functions by disease area without regard to modality; former commissioners give some support but new drugs Director Jenkins warns about unintended consequences that could negatively impact innovation and approvals.

Melanoma Approvals Break New Ground In Immunotherapy

First adjuvant and combination approvals for immuno-oncology could help revive Yervoy in melanoma; Amgen’s oncolytic cancer vaccine emerges as new mechanism for select patients, with room to grow.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS057597

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