Posted by Michael Wonder on 05 Oct 2019
FDA grants breakthrough therapy designation to cobimetinib for MEK inhibition in histiocytic neoplasms, research led by MSK
2 October 2019 - Memorial Sloan Kettering Cancer Center announced today that the US FDA has granted a breakthrough therapy designation to cobimetinib in treatment of patients with histiocytic neoplasms (Erdheim-Chester Disease, Rosai-Dorfman, Langerhans Histiocytosis), who do not harbour the BRAF V600 mutation.
Cobimetinib is an oral inhibitor of MEK1 and MEK2 currently approved to treat melanoma.
This designation was granted based on data submitted by Memorial Sloan Kettering Cancer Center, in collaboration with Genentech, a member of the Roche Group, from a phase II trial of single-agent cobimetinib for adults with histiocytic disorders.
