Boston-based biopharmaceutical company, Verastem Oncology, has announced that the US Food and Drug Administration (FDA) has granted their avutometinib and sotorasib combination a fast-track designation for the treatment of non-small cell lung cancer (NSCLC).
Fast-Track Designation for KRAS G12C-Mutant Metastatic NSCLC
The fast-track designation specifically applies to patients with KRAS G12C-mutant metastatic NSCLC who have previously undergone at least one systemic therapy and have not been treated with a KRAS G12C inhibitor before.
Accelerated Development and Review Process
The FDA’s fast-track designation aims to expedite the development and review of drugs that address serious or life-threatening conditions and fulfill unmet medical needs. This designation is expected to accelerate the overall timeline for the combination’s development.
Significance of the Combination
Verastem Oncology highlights the significance of this combination, as KRAS G12C is the most common KRAS mutation found in NSCLC. The advancement of this treatment approach offers potential new options for patients.
CEO’s Perspective
Chief Executive Dan Paterson expressed his optimism regarding this development, stating, “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.”