Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model
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received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.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.