CAR-T therapies, approved to treat several types of blood cancers, have been inaccessible to 80% of eligible patients because of geographic and logistical hurdles. 

Galen/Atlantica was engaged by the Alliance for Regenerative Medicine (ARM) to engage with FDA on CAR-T class labeling restrictions.  We advanced evidence-based argument based on real-world data to justify streamlining monitoring requirements.

FDA issued class-wide labeling change limiting a patient’s need to stay in proximity to a specialized treatment center for two weeks (previously four weeks) and restricting driving to two weeks after treatment (down from eight weeks). These changes are expected to significantly broaden CAR-T access.