Published on 24 Jan 2024 on Zacks via Yahoo Finance
Verastem Oncology VSTM announced that the FDA has granted the Fast Track designation to its investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s AMGN Lumakras (sotorasib), for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC).
The FDA’s Fast Track designations intend to expedite development and review timelines when preliminary nonclinical and clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions.
The Fast Track tag enables close communication between the FDA and sponsor in improving the efficiency of product development to get new therapeutics to patients faster.