New data support third indication for Kymriah
Swiss pharma giant Novartis (NOVN: VX) today announced positive results from the Phase II ELARA trial of Kymriah(tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).
At the interim analysis, the global study met its primary endpoint of complete response rate (CRR), as assessed by independent review committee. CRR is a standard measure of patient response to therapy in FL. No new Kymriah safety signals were observed.
Results from the ELARA trial will be presented at an upcoming medical meeting and pave the way for regulatory submissions for the new indication, with filing in the USA, where Kymriah was granted Regenerative Medicine Advanced Therapy (RMAT) status, anticipated in 2021 and in the European Union thereafter.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze