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

UsernamePublicRestriction

Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

Executive Summary

Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.

You may also be interested in...



CAR-T Cell Product Development Guidance Covers Previous Recipients, ‘Bridging Therapy’

Testing of autologous therapy in clinical trial patients who previously received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.

CMS' Verma Touts Value-Based Payments After Cancellation Of Pilot For Novartis' Kymriah

'It's not for every medication,' CMS administrator says, but agency continues to explore how to apply value-based pricing.

Immuno-Oncology: Execs Talk About Tumor Response, Biomarkers, Lessons Learned

Leaders from Novartis and other companies developing cellular gene therapies share insights they've gleaned on manufacturing, clinical trials, and value-based pricing.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121433

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