Verastem Oncology gains Fast Track Designation for combination NSCLC treatment
Betsy Goodfellow | January 19, 2024 | News story | Medical Communications | Cancer, FDA, NSCLC, Oncology, Verastem Oncology
Verastem Oncology has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s KRAS G12C inhibitor, Lumakras (sotorasib) for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC).
Preliminary results from the phase 1/2 RAMP 2023 study evaluating the safety and efficacy of this combination in patients with KRAS G12C-mutant NSCLC demonstrated confirmed responses in both KRAS G12C inhibitor resistant and naïve patients.
Initial RAMP 203 results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in October 2023.
Dan Paterson, president and chief executive officer of Verastem Oncology, commented: “Receiving Fast Track Designation for the combination of avutometinib and sotorasib reinforces the importance of improving the depth of MAPK pathway inhibition to enhance tumor regression relative to KRAS G12C inhibition alone and the potential of the combination of avutometinib and sotorasib in KRAS G12C mutant locally advanced or metastatic NSCLC. Given that KRAS G12C is the most common KRAS mutation in NSCLC, the advancement of the combination is important in understanding potential new treatment approaches. We look forward to continued interaction with the FDA as we advance the development of this promising treatment regimen.”
Betsy Goodfellow
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