NEW YORK – The US Food and Drug Administration has granted expanded access to BioMed Valley Discoveries' investigational ERK inhibitor ulixertinib for patients with cancers driven by alterations in the MAPK pathway.
The drug will be made available through an intermediate-sized expanded access program (EAP) facilitated by xCures, a company that uses machine learning algorithms to identify cancer patients for drug trials and collects real-world data on patients' outcomes within those studies, which in turn can be used to support regulatory submissions for investigational drugs.