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.

Advertisement

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

Related Content

AI in pharma: From lab development to patient impact

In the decade to 2025, AI use in vaccine development has increased markedly but is …

FDA grants De Novo authorisation to light-filtering device for migraine

The US Food and Drug Administration (FDA) has granted De Novo marketing authorisation to Avulux, …

EndoCyclic New Drug application approved by US FDA for endometriosis treatment

EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved …

The Gateway to Local Adoption Series

Latest content