28 July 2020 - BioMed Valley Discoveries announces the receipt of fast track designation from the US FDA for investigation of the ERK inhibitor ulixertinib (BVD-523) as a treatment for patients with non-colorectal, solid tumours that harbour BRAF mutations G469A/V, L485W, or L597Q.
BVD has launched a Phase II multi-center study of ulixertinib for patients with advanced malignancies harbouring these atypical (non-V600) BRAF alterations or a MEK alteration.
Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug.